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What does a clinical research associate do?

Clinical research associates (CRAs) are responsible for running clinical research, which consists of trials designed to test new or current drugs/immunisations and analyse their effectiveness, risks, benefits and safety of use. 

CRAs play an important role in the healthcare industry and public health development by helping to design and test new medications, vaccinations and other therapeutic agents.

CRAs can be involved at any stage of a drug development trial, including planning, coordinating and supervising. It is their responsibility to ensure a drug has been appropriately examined and all its risks have been evaluated before it is released to be used publicly.

CRAs most commonly work for pharmaceutical companies or contract research organisations. They might also have to spend some time working in a hospital setting to collect data about the drugs they are analysing. They might also work for universities or public/global health organisations. 

As a CRA, you may have a range of responsibilities depending on your employer, project and level of experience. Typically, CRAs will need to complete tasks such as:

• Designing and writing trial protocols and standard operating procedures
• Presenting protocols and procedures to steering committees
• Designing data collection forms
• Requesting ethics approvals and working with ethics committees
• Liaising with staff conducting the trials, such as doctors or consultants
• Training local staff based on trial-specific standards
• Monitoring operations during clinical trial data collection
• Collecting completed data collection forms
• Performing data management and analysis, and discussing the results
• Closing trials and finalising reports with the help of a statistician

CRAs will work in a team of other research professionals, including contract organisation or sponsor staff, principal investigators and clinical research coordinators.

How to become a clinical research associate

To become a CRA, you need to obtain a degree in medical sciences, life sciences or nursing. This can be in subjects such as biomedical science , anatomy, physiology, immunology , pharmacology or broader degree subjects like chemistry and biology .

Alternatively, you can access a career as a CRA by acquiring a higher national diploma (HND). This is a qualification equivalent to the second year of a bachelor’s degree. HNDs can be beneficial to those who want to enter more practical fields, clinical research included.

Occasionally, you can enter a CRA role from an administrative background. For instance, if you begin working as a clinical trials administrator/assistant and decide you would prefer the role of a CRA, you can complete additional qualifications to do this. However, this will take some time and can be difficult.

Most employees view undergraduate qualifications as sufficient, but in some cases a postgraduate degree may be beneficial. Master’s degrees and PhDs can gain you an advantage when applying for competitive positions, and help you gain more experience in research .

Work experience is key to securing a clinical research job. You can get this at any point in your training, and some universities may help with this. The types of work experience most useful for a CRA role include:

• Academic research
• Pharmaceutical research (e.g. via a pharmaceutical industry placement during your degree)
• Laboratory work
• Nursing or care work
• Work in a pharmacy or medical sales
• Other, similar activities

How long does it take to become a clinical research associate?

Becoming a CRA will usually take around three to four years, depending on the access pathway you choose.

If you opt to complete an undergraduate degree, this can take three to four years. You can then apply to job positions as a CRA straight away. However, if you don’t have sufficient work experience, you may need to start at a lower-level position such as a more administrative job. From here, you can gain more experience and reapply for a higher-level position.

If you choose to obtain a HND qualification, this will take two years. Provided you have sufficient experience, you can then apply for a graduate post as a CRA, but again you may need to gain some extra experience/qualifications in some cases.

If you opt to do a postgraduate degree first, this may take an additional one to three years depending on whether it is a master’s degree or a PhD. Many CRA job positions also allow for completion of postgraduate qualifications alongside the job.

A day in the life of a clinical research associate

Most CRAs work about 40 hours a week, during weekdays. There may be an out-of-hours commitment, for instance if working in a hospital setting monitoring a new drug, but this is dependent on your employer and role.

CRAs can work on multiple trials at a time, in multiple different sites. This will depend on the complexity of each trial and what stage each of the trials is in. Therefore, the role may entail some travelling at times, while other times most of your work will be concentrated on one site.

As a CRA, you will carry out a wide variety of tasks. Some days may be spent writing reports. On other days, you will work on site with healthcare staff , or you might go into your office and attend meetings.

No matter your experience level or how senior your role is, as a CRA, you will need to work in a team with other research and healthcare professionals. You will be communicating with research nurses, doctors, health consultants, investigators and managerial and administrative staff from the company requesting the trial.

The role requires good communication skills, as well as good time management and organisation skills, because carrying out a few different studies at once may mean some tasks clash with one another and you need to prioritise the most important ones.

Clinical research associate: Career options

As with most clinical roles, CRAs undergo lots of continuing professional development (CPD) within their role. There are many training courses available to CRAs to build on their existing skills and develop new competencies.

Most training courses are organised by external bodies, and many are paid for by the employer. One of the organisations that runs training courses is the Institute of Clinical Research (ICR). It provides training in areas such as effective project management for clinical trials and advanced clinical trial monitoring, among several others.

The ICR also offers certificates and a diploma that you can complete to evidence your skills in clinical research. Becoming an ICR member and obtaining courses and qualifications from it can also be beneficial to career development, as you will meet other prominent professionals in your field through interacting with this organisation.

You can also opt to complete a postgraduate qualification, such as a PhD or master’s degree in several different areas, including clinical research and clinical pharmacology .

As mentioned, you may need to climb up the professional ladder to become a CRA, and many people start off as clinical trial administrators or junior CRAs. Within these roles, you might complete tasks such as handling documentation and correspondence or helping to set up trial sites. 

From here, you can move on to becoming a senior CRA as you gain experience. At this point, you will have more advanced responsibilities, such as project management of whole trials and designing case report forms.

If you develop sufficient experience and gain contacts in the field, there is a possibility of self-employment if you want to become a freelance CRA. 

Salary: How much does a clinical research associate earn in the UK and US?

In the UK, starting salaries for CRAs range between £26,000 and £34,000 per year. As a more senior CRA, you might earn between £35,000 and £50,000, and in the most senior positions involving managerial tasks, you might earn upwards of £55,000.

Salaries will vary between regions and employers, as well as depending on your level of experience and responsibilities. Some companies offer additional benefits.

In the US, the average salary for a CRA is $70,000 per year. The range is between $60,200 and $80,900. This can vary depending on the region you work in, your education and experience levels and any additional qualifications you have.

Salaries will also be different as a freelance CRA, and this will depend on the number of clients you have and any business-related expenses you need to cover.

• Prospects. Clinical research associate. Available from: https://www.prospects.ac.uk/job-profiles/clinical-research-associate (accessed Apr 2024)
• CK Group. Clinical research associate (CRA) job profile. Available from: https://ckgroup.co.uk/candidate/job-profiles/clinical-research-associate-cra-job-profile/ (accessed Apr 2024)
• Nikolova, T. The CRA Wizard. How to become a CRA for dummies in 7 steps (or less). Available from: https://www.thecrawizard.com/how-to-become-a-cra-for-dummies (accessed Apr 2024)
• Glassdoor. Clinical research associate career. Available from: https://www.glassdoor.co.uk/Career/how-to-become-clinical-research-associate_KO14,41.htm (accessed Apr 2024)
• Coursera. How to become a clinical research associate. Published Nov 2023. Available from: https://www.coursera.org/articles/clinical-research-associate
• Walters, L. Pharmiweb.jobs. 8 ways to advance your career as a clinical research associate (CRA). Published Sept 2023. Available from: https://www.pharmiweb.jobs/article/8-ways-to-advance-your-career-as-a-clinical-research-associate-cra- (accessed Apr 2024)
• Salary.com. Clinical research assistant salary in the United States. Available from: https://www.salary.com/research/salary/alternate/clinical-research-assistant-salary (available from Apr 2024)

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Clinical Research Associate Job Description

Clinical research associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs, and procedures. A clinical research associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

Clinical Research Associate Job Description Template

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Clinical Research Associate Responsibilities:

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Clinical Research Associate Requirements:

• Bachelor’s degree in biological science or a related field.
• 2+ years of experience as a clinical research associate.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Strong verbal and written communication skills.
• Proficient computer skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.
• Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
• Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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Biochemist job description, chemical engineer job description, clinical research associate interview questions, biochemist interview questions, chemical engineer interview questions, clinical research associate resume.

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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How to become a clinical research associate (CRA)

Clinical research is an important step in developing and evaluating new medical products. For people with qualifications or experience within life sciences , a career in clinical research can offer many rewarding, interesting and varied opportunities and career paths . With the demand for new prevention methods and treatments ever increasing, clinical research associates are needed by pharma, biotech, medical device companies and CROs around the world. Here are some things to consider if you’re looking to kick-start a career in clinical research and how to become a clinical research associate:

What is a clinical research associate?

'A clinical research associate (CRA) is someone who monitors the running of clinical trials. A CRA may be involved in some or all stages of the clinical trials process depending on the type of position or the employer.

What are the responsibilities of a clinical research associate?

Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

If you are a field-based CRA, you will spend most of your time travelling to different locations, dealing with medical professionals in trial centres, healthcare practices, or hospitals. The remainder of your time may be spent either office-based or working from home, but this will depend on the company. Some companies will have in-house CRA roles who just focus on document review and management and will make site visits only occasionally.

What is the demand for clinical research associates?

Driven by a rise in the number of healthcare facilities, increasing healthcare expenditure, technological and research capabilities, and an aging population, the need for new treatments has increased exponentially in recent times. This has led to a rise in the number of companies hiring for new clinical research jobs and this is likely to keep gaining momentum in the years to come.

What qualifications or training do I need to get a clinical research associate job?

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven’t got the desired qualifications.

Qualifications:

Although not usually necessary, a Master's degree (MSc. or equivalent) or a PhD can be advantageous and could give you valuable experience in clinical research. A relevant PhD can also be beneficial, as some companies will see this as relevant work experience and count it towards reaching promotions to more senior positions.

Certifications:

The Association of Clinical Research Professionals (ACRP) offers a certification exam to become a Certified CRA. Even though, for most CRA roles, this is not a requirement, being CCRA certified is a real advantage. The exam covers everything a CRA will need to know from scientific concepts and research design to product development and regulation, to data management.

There are lots of courses out there that can provide you with a detailed understanding of what it takes to a be CRA. Before you sign up to anything, make sure it is a recognised training course that is recommended by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

How do I get the right experience for a clinical research associate job?

Getting your first job in clinical research can be challenging, and many graduates at the start of their clinical research career can become frustrated by the 'catch 22' scenario: they can't find work because of a lack of experience and they can't get experience because they can't find work.

Without relevant work experience, you will be more likely to secure a job as a clinical trials assistant (CTA). A CTA role will help support all processes of the trial and give you the required experience to move into a clinical research assistant role.

Generally, larger companies are far better equipped to take-on inexperienced graduates and are more likely to offer programmes such as graduate assessment days and internships. Research who the top pharmaceutical companies , medical device manufacturers and contract research organisations are, and look out for opportunities on their career websites. Their social media pages are also great places to find out about graduate programmes, so keep a close eye on them too.

You might be able to gain experience by working on academic projects or working within a healthcare body. Although these are good ways to gain experience, moving into a commercial environment later can be quite different and you might have to take a more junior position with a lower salary than you are used to.

Tips for applying to clinical research jobs            

Even with all the relevant qualifications, skills and experience that you need to become a clinical research associate, there can still be challenges in landing your perfect clinical research job . A few simple changes to your approach can give your CV a better chance of success .

Be realistic

Be realistic about the types of jobs that you can attain. If you don’t have industry experience, you are unlikely to be hired for anything above an entry level role. Don't apply to senior CRA jobs or clinical project manager roles unless you have been working as a CRA for some time already and have the required experience. Save yourself the time and effort in making lots of speculative applications and take a more targeted approach.

Highlight your relevant experience

If you are applying for a clinical research associate job , ensure that you read each job description carefully and highlight on your CV the relevant experience that matches the specific description. Your cover letter should be personalised to the specific company and describe why you want to work for that company and which of your skills match the specific requirements of the role. Employers and life sciences recruitment consultants are looking for the most relevant applications and will readily discard those that have put little effort into personalising it.

Make sure you network

Remember, not every company will advertise all its vacancies so you should consider other approaches too. Networking with recruiters and hiring managers and uploading your CV to a database are two great ways that employers and recruiters with CRA jobs can find you.

What are the different career paths you can take?

There are a variety of ways to progress your career in clinical research , with pharma, biotech, and medical device companies and CROs all offering opportunities. Roles will vary from company to company but typically CRAs will progress to be a senior clinical research associate. With the right experience, CRAs will have the potential to progress all the way to clinical director or even VP level.

Once a CRA has reached senior level, there are typically three main routes a career in clinical research can take. You will either be a manager of the trial process, a manager of people or a project manager.

Clinical trial management:

Usually responsible for managing, coordinating, and overseeing various aspects of the trial. Typical duties will involve supervising staff, implementing study tools and documents, overseeing trial budgets and providing strategic input into trials.

Clinical team management:

Responsible for acting as the direct line manager to associates. Clinical team managers will manage and support team members, ensure staff are trained effectively, review the effectiveness of business processes and plan professional development activities.

Clinical project management:

Involved with the planning and directing of clinical trials and is also responsible for evaluating clinical data. Day-to-day tasks include, maintaining study records, ensuring activities are being delivered on time and on budget, interpreting study data and developing trial plans.

Are you already a CRA professional or looking to start your career in clinical research? We might have something that is the right fit for you. We are looking for experienced professionals for a broad and extensive range of clinical research positions. Take a look at our latest clinical research jobs and apply today.

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CCRA Certification

Ccra® (certified clinical research associate) is a credential formally recognizing clinical research professionals with experience monitoring and supervising the conduct and progress of clinical trials on behalf of a sponsor., this trusted mark of excellence in clinical research is awarded to clinical researchers who have demonstrated proficiency of specific knowledge and skills by passing the standardized ccra® certification exam..

Apply for Your Exam

Clinical research professional with 3,000 hours of verifiable work experience are eligible to sit for the CCRA ® Exam. Complete eligibility criteria is defined in the Academy’s  policy manual .

What qualifies as work experience, work related to human subject research, paid contractual agreement – employer/employee, can be verified by acrp through employer, what is excluded from work experience, any work that is part of a degree track or education program, any experience older than ten years, internships paid or unpaid.

Clinical research professionals with 1,500 hours of verifiable work experience and a clinical research degree are eligible to site for the CCRA ® Exam.

What qualifies as a clinical research degree, any degree awarded in clinical research from a chea accredited institution, major in clinical research, what does not qualify, any degree not in clinical research (biology, psychology, public health, epidemiology, nursing, doctorate), graduate certificate programs.

The CCRA ® exam consists of 125 multiple choice questions that must be answered within 180 minutes.

The exam is referenced only to the international conference on harmonization (ich) guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)., the following are the only references for which the ccra ® certification exam content can be supported:, ccra ® exam detailed content outline >, guideline for good clinical practice e6 (r2) >, definitions and standards for expedited reporting (e2a) >, general considerations for clinical trials (e8) >, statistical principles for clinical trials (e9) >, clinical trials in pediatric population (e11) >, the declaration of helsinki (doh) >, the global ccra ®  exam committee uses psychometrically sound practices to develop certified clinical research associate (ccra) examinations that meet the current test specifications as determined by the most recent job task analysis (jta)..

Review the Detailed Content Outline and make sure your experience and work hours are appropriate, as outlined in the Eligibility tab.

We also strongly encourage you to review the entire acrp certification handbook , which provides full details about every facet of acrp certification..

Create a free ACRP account so you can begin the application process. Follow the on-screen prompts to enter any requested information and documentation.

If you already have an acrp account, please proceed to step three., create account >.

You’re almost there! Please note, applications selected for audit will undergo a formal review by ACRP’s subject matter experts. In most instances, you will receive a status update about your application within 7 business days.

In accordance with the americans with disabilities act, acrp will provide reasonable accommodations for candidates with disabilities. please complete this special accommodations form for submission with your application before proceeding., acrp’s testing partner psi offers in-person testing, as well as on-demand remote testing available 24 hours a day, every day, during the testing windows., watch these videos to learn what to expect from each option before scheduling your exam..

Find Test Centers Near You >

Schedule your in-person exam >.

Schedule Your Remote Exam >

Check system requirements >.

The best way to prepare for the CCRA ® exam is to fully understand the scope of the exam content and its references.

Please be sure to thoroughly review the following:, acrp certification handbook >, remember: the exam is referenced only to the international conference on harmonization guidelines. no other regulatory framework is tested, including country-specific regulations (i.e, fda or ema)..

We also recommend leaning on your community! Thousands of ACRP Certified members have been in your shoes. They are active community members and always willing to share tips and advice for ACRP exam prep.

Visit the acrp community >.

ACRP offers a variety of training and continuing education programs focused on the key ICH guidelines covered in the CCRA ® exam.

Learn more >.

Exam results are shared immediately at the conclusion of your exam, but PSI will send you an email with your full score report within 24 hours.

Your acrp account will reflect your results within 3 weeks of your exam date..

Congratulations! You just passed a major milestone on your professional journey and are now a member of the elite club of ACRP Certified clinical research professionals.

Keep an eye on your email because you will soon receive information from our digital badging partner credly about claiming your digital badge and how you can use it to tout your accomplishment. also learn how to use your new credential by reviewing the  certification mark policy ., you have 2 years to keep your certification in good standing by continuing your professional development, and we’ll be right there with you every step of the way. in the meantime, we highly recommend you review all the details about maintenance of certification . don’t leave it to the last minute.

Don’t worry. It happens to the best of us. Give it another try!

Refer to your acrp certification examination results email or the acrp certification handbook for guidance on the next steps in your certification journey., upcoming testing dates, spring 2024 testing february 15 – may 15, 2024, fall 2024 testing july 15 – october 15, 2024, 2024  registration dates and fees, early bird registration acrp members – $435 nonmembers – $485 spring 2024:  october 15 – december 31, 2023 fall 2024:  may 15 – july 15, regular registration acrp members – $460 nonmembers – $600 spring 2024:  january 1 – april 30 fall 2024:  july 16 – september 30, join acrp & save, joining acrp helps you save money. more importantly, acrp is where you will find the very best of what you need to design a career path that’s uniquely your own. connections through an engaged community. growth through gold-standard training. and elevation through rigorous certification., explore membership >, exam preparation, congratulations on your decision to earn the most recognized and respected endorsement of clinical research competency — acrp certification. as you start this important journey in your career, we’re here to support you every step of the way..

Clinical Research Associate: A Full Guide on Becoming A CRA

Clinical Research Associate

A complete guide on how to become a clinical research associate.

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care.

As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree.

This is why a career as a CRA should be considered with clinical research coordinator training. We train over 500 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

For those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career.

Because the position is unlike actually working in the lab and more of a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered).

Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year: an amount that is uncommon in other science-degree careers.

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. T

his is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Clinical Research Associate Certification Qualifications

Foreign Doctors Welcome : A Clinical Research Associate or Coordinator plays a vital role in directing and supervising clinical trials conducted by physicians, nurses, and other science professionals. This career path is particularly attractive to many foreign doctors with completed medical degrees (MBBS) who can utilize their expertise in the US healthcare system by pursuing a CRA career instead of taking the USMLE or repeating residency training. For those interested in coordinating aspects, consider the Clinical Research Coordinator course .

Distinct Skillset : Unlike the traditional medical field you may be familiar with after years of schooling, Clinical Research Associate training provides a distinct and valuable skillset. For comprehensive understanding of Good Clinical Practice, see the ICH-GCP course .

Most Extensive Online Course : Our program goes beyond basic introductions, offering a comprehensive curriculum with over 110 modules – the most extensive Clinical Research Associate course available online. This in-depth training ensures you're well-prepared to secure a coveted CRA position.

Superior Coursework : Securing a CRA role is a strategic career move compared to the limitations of many traditional medical positions. While generic courses abound, we've observed that graduates often struggle due to a lack of substantive content. Our Clinical Research Associate course addresses this gap by providing Senior Clinical Research Associate-level training through 110 intensive modules grounded in the latest scientific principles. For those looking to assist in clinical trials, the Clinical Trials Assistant Training may also be of interest.

Diverse Career Opportunities : This high-demand science-based medical field offers diverse opportunities:

Work in the Private Sector : Pursue a CRA career with renowned pharmaceutical companies like Pfizer. Enhance your skills with the Advanced Clinical Research Project Manager Certification .

Academic Opportunities : Work in the academic sphere at medical schools. Those aiming for higher responsibilities may consider the Advanced Principal Investigator Physician Certification .

Unmatched Flexibility and Knowledge : In addition to our exceptional course content, we boast the largest number of clinical research courses available online, providing you with unmatched flexibility and knowledge. For those interested in safety monitoring of drugs, the Pharmacovigilance Certification and Medical Monitor Certification can enhance your capabilities in these critical areas.

Why Take A CRA Certification Course

 The role of the clinical research associate is to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. For example, you may find associate degree programs. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for a fully online program, you can still get an immersive education. Different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as the lecturers.

Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order for students to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields (like medical assistants or nurses) and are interested in moving to the field of clinical research.

They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials.

During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective. The need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience in clinical trials.

Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate , ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to.

Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might increase your chances.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

The Best CRA Certification Course For Entry-Levels

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training.

Our program is considered one of the top clinical research graduate programs online. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts.

Because our modules are prepared help even Senior Clinical Research Associates, we find more of our students with no background quickly passing their interview rounds.

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail.

After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing.

This advantage allows many students with limited experience to get hired with a higher paying job than previously offered.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. nonetheless, we train all students at a Senior CRA level regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken.

Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat. Medical knowledge is supplemental but not sufficient in this career path.

This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

How To Get Experience For Clinical Research Associate Jobs

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

The ICH-GCP in Clinical Research

Regardless of the type of clinical research or function of an IP being tested, it is important that clinical research should meet two critical criteria:

The clinical research process should respect the rights, freedom and dignity of tested patients (human participants).

Data from the clinical research process should be accurately collected, safely stored, rigorously scrutinized and correctly interpreted.

One way to ensure that these requirements are met is to follow a set of internationally recognized and accepted standards for clinical research. 

Most countries across the world today follow ICH-GCP, that is, International Committee for Harmonization of Good Clinical Practice guidelines in conducting clinical research on human participants7.

The ICH-GCP outlines procedures and precautions that are essential in order to protect the safety and wellbeing of human research participants during clinical research, and to ensure the integrity of data from clinical research studies.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.

In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’8.z

Qualifications and Qualities of a CRA

According to the International Accrediting Organization for Clinical Research (IAOCR), candidates for CRA positions usually hold either a biological science degree, or one in medicine or nursing10. 

The New Scientist recommends that aspiring CRAs should possess a good working knowledge of one or more of the following subjects – anatomy, biology, biochemistry, chemistry, immunology, microbiology, pharmacology, physiology or toxicology11.

In addition to a background in medical or life sciences, a CRA is required to have a good grasp of data management, including Electronic Data Capture (EDC), data analytics and reporting12.

Sketching the CRA work profile, the authors Diane St. Germain and Marjorie Good state that CRAs are the ones who scrutinize clinical study data most closely from start to finish—as a result, they are often the first to notice critical patterns and interesting trends, and to report these to the research team as well as to the CRO13.

Equally if not more importantly, a CRA must possess a high level of emotional and interpersonal savvy. This is a crucial area, since a CRA’s success hin ges upon his/her ability to elicit the best from team members, in terms of both performance and probity. 

Core Competency Framework for CRAs

To illustrate, the ACRP’s ‘Core Competency

Framework for Clinical Study Monitoring’

requires that a CRA should be able to identify

and correct compliance violations at a study

site. The CRA must not only bring such

violations to the attention of site staff, s/he

must induce them to take corrective action,

as well as reporting the matter and even

escalating it, where necessary14.

The table below summarizes the ideal

competencies of a CRA, and provides

insights on how each ability contributes to

the CRA’s performance.

CRA Career Path

In the past, CRA positions were often filled by individuals with medical or nursing backgrounds, with little thought given to their lack of research training15. As awareness grew about the importance of research experience for a CRA, employers began preferring those with years of experience in clinical research settings, such as Clinical Trials Assistants (CTAs) and Clinical Research Coordinators (CRCs)16.

However, in recent years, the focus has shifted once again from a tenure-based mindset to a skills-based evaluation17. In part, this change has been brought about by the growth in professional courses and training programs in the field. 

For instance, many leading US Universities today offer master’s programs in clinical research18. In addition, there are some widely recognized certification programs for clinical research associates, such as those offered by the ACRP19 and the Society of Clinical Research Associates (SOCRA) 20.

Note: You must already be working as a CRA to qualify for the ACRP and SOCRA certification programs.

A Toe in the Door: CRA Certification for a Non-CRA

By this point, you might be wondering, “I have no research experience… I’ve never worked as a Clinical Trials Assistant (CTA) or a s a Clinical Research Coordinator (CRC). Nor do I have a degree in Clinical Research. Can I still become a CRA?”

The simple answer is, yes, you can.

You might be a life sciences graduate looking for a lucrative career in the pharmaceutical or biotechnology sectors. Or, you’re excited by a career in research, but unsure whether the drudgery of a Ph.D. is your thing.

Maybe you’re just looking for a job that represents a great option for someone with your combo of science background plus detail-orientedness.

Whichever of these descriptions best applies to you, a career as a Clinical Research Associate could be exactly right for you.

With the right training, you can be recruited directly to a Clinical Research Associate position, even without a background in clinical research.

So, what kind of training will help me break through the ‘experience’ barrier and land a job as a CRA?

As you’ve already gathered from the table, the skill-set required to be a successful CRA is pretty extensive.

Aside from an in-depth knowledge of scientific and medical concepts and principles, a CRA must have a sound grasp of medical research regulatory requirements, a penchant for being thorough and systematic, as well as a knack for coordinating and managing people with diverse skills, roles and backgrounds.

To our knowledge, CCRPC’s ‘Advanced Clinical Research Associate Certification’ (ACRAC) is one of a kind: The ACRAC is the only multi-accredited* certification program in the US that offers the kind of exhaustive as well as intensive training that equips candidates from a non-clinical background with the abilities and competencies that make a good CRA.

Best of all? The ACRAC is open to fresh graduates holding a B.S. degree in any of the life sciences, with no requirement for prior exposure or experience in clinical research.

*The ACRAC program offered by CCRPC is accredited to ACCRE (Accreditation Council for Clinical Research & Education), ACCME (Accreditation Council for Continuing Medical Education), ACPE (Accreditation Council for Pharmacy Education), ANCC (A merican Nurses Credentialing Center), as well as Transcelerate Biopharma.

Training to be a CRA through CCRPS ACRAC

The ACRAC program includes over 100 course modules that cover all the important knowledge domains and skill-sets required by a CRA.

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Starting with a broad overview of clinical research jargon and terminology, the course walks students through the principles of Good Clinical Practice, familiarizing you with the relevant sections of the ICH-GCP and the FDA’s E6(R2).

The program places particular emphasis on ethical practices in research with vulnerable populations.

Students going through the ACRAC are trained in all major aspects of designing a Clinical Trial Protocol in keeping with the Code of Federal Regulations (CFR).

They additionally learn the steps involved in the IRB/IEC approvals process and how to prepare required documents.

Finally, students become aware of the importance of pharmacovigilance and the regulatory process for new drug testing.

A major chunk of the ACRAC certification centers around equipping the CRA for day-to-day responsibilities, such as different types of site visits – preliminary (Site Qualification), preparatory (Site Initiation) and progress monitoring visits (Routine Monitoring).

Crucially, the ACRAC covers essential documentation such as the Case Report Form and Trial Master File, as well as electronic data capture (EDC) and remote monitoring systems.

A vital component of the training program involves empowering students to tackle challenging situations.

For a CRA, these include identifying protocol deviations and violations, and recognizing as well as reporting research fraud and ethical misconduct.

In addition to its comprehensive coverage, the ACRAC certification offers the great advantage of including 17.5 CME credits – that is, course credits that count towards ‘Continuing Medical Education’.

These credits can be used by individuals desiring to further their education and/or careers in healthcare-related fields, including medicine, nursing, pharmacy and research.

Clinical Research Associate Training

Get ahead in clinical research with advanced accredited online CRA certification for $450. Demo our on-demand course below.

Clinical Research Associate Certification

Advanced clinical research associate certification (acrac).

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on. 

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as  Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects. 

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling. 

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts. 

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.   

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.  

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel. 

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions. 

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined.  The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies. 

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

 This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators. 

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF. 

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process. 

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates 

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV)  – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter  – document notifying site PI of appointment of new monitor (yourself as CRA) 

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position. 

https://www.beroeinc.com/category-intelligence/clinical-research-organizations-market/

https://www.linkedin.com/jobs/search?keywords=Clinical%20Research%20Associate&location=United%20States&geoId=103644278&trk=public_jobs_jobs-search-bar_search-submit&position=1&pageNum=0

https://www.centerwatch.com/articles/24791-demand-for-experienced-clinical-trial-professionals-outpacing-supply-acrp-says

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3317309/

https://www.niaid.nih.gov/research/dmid-investigational-product

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

https://www.fda.gov/files/drugs/published/E6%28R2%29-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6%28R1%29.pdf

https://www.who.int/groups/research-ethics-review-committee/recommended-format-for-a-research-protocol/

https://iaocr.com/finding-first-clinical-research-job/

https://jobs.newscientist.com/en-au/article/a-career-in-clinical-research/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/

St. Germain DC, Good MJ. 2017. Data management in clinical trials. In: Gallin JI, Ognibene FP, Lee Johnson L, editors. Principles and practice of clinical research. San Diego: Academic Press. p. 531-545. ISBN 978-0-12-849905-4

https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/04/clinical-study-monitoring-competencies.pdf

https://www.clinicalleader.com/doc/starting-a-career-in-clinical-research-things-we-wish-we-knew-0001

https://www.proclinical.com/blogs/2021-9/how-to-get-a-job-as-a-clinical-research-associate-cra

https://acrpnet.org/2018/06/11/5-clinical-research-trends-emerge-at-acrp-2018/

https://www.collegechoice.net/sciences/clinical-research/best-masters-degrees/

https://acrpnet.org/certifications/cra-certification/

https://www.socra.org/certification/program-overview/

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

The ultimate guide to clinical research monitoring.

• Candidate Eligibility

SOCRA offers one comprehensive clinical research certification so there is no need to obtain multiple certifications when you transition to varying roles in the clinical research arena. Available to all persons working in clinical research: SOCRA members enjoy reduced certification fees, while non-members receive complimentary SOCRA membership upon passing the exam. Whether you are independent or affiliated with a research institution, or you're an investigator, coordinator, monitor, nurse, or any other role – SOCRA's CCRP is your credential of excellence.

Eligibility Criteria

The applicant must meet one of the following Eligibility Criteria noted below.   Please note that most candidates will be eligible under Category 1.

The applicant must be working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

For purposes of eligibility, please view SOCRA's definition of a Clinical Research Professional .

If you have a question about Candidate Eligibility please email SOCRA at  [email protected]

Applicant must have (and be able to document) ALL of the following qualifications:

• Have two years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last five years

Please note:  If you have completed two (2) years of full-time employment as a clinical research professional in the past five years, you will NOT need to provide supporting documentation for your educational experience.

• Hold a degree in "Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" from an Associate, Undergraduate, or Graduate Degree Program AND
• Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional
• Hold an Undergraduate or Graduate Certificate in “Clinical Research conducted with humans according to the principles of Good Clinical Practice GCP" with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND
• Hold an Associate’s or Bachelor’s Degree in a science, health science, pharmacy or related field AND
• Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional .

Certification

• Program Overview
• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Exam Overview
• Application and Fee
• Computer Based Testing Exams
• Paper and Pencil Exams
• Refunds, Rescheduling and Retesting
• SOCRA Sponsored Exam Schedule
• Preparing for the Exam
• Preparation Resources
• Examination Results
• Host an Exam at Your Site
• Apply Online
• Exam Schedule SOCRA Sponsored Sites
• Requirements for Maintaining Certification
• Continuing Education Requirements
• Descriptions of Acceptable CE
• CE Recordkeeping Requirements
• Request for SOCRA CE for Courses / Workshops
• Installment Plan Payment
• Renewal of Certification
• Recertification Audit
• Recertification Learning Module
• Accreditation

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Senior / Clinical Research Associate Job Description

Senior / clinical research associate duties & responsibilities.

To write an effective senior / clinical research associate job description, begin by listing detailed duties, responsibilities and expectations. We have included senior / clinical research associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Senior / Clinical Research Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Senior / Clinical Research Associate

List any licenses or certifications required by the position: CCRA, CCRP, CCRC, GCP, ACRP, CRA

Education for Senior / Clinical Research Associate

Typically a job would require a certain level of education.

Employers hiring for the senior / clinical research associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Health, Nursing, Pharmacy, Medical, Education, Biological Science, Life Sciences, Life Science, Science, Health Care

Skills for Senior / Clinical Research Associate

Desired skills for senior / clinical research associate include:

Desired experience for senior / clinical research associate includes:

Senior / Clinical Research Associate Examples

• Microsoft Word (.docx) .DOCX
• PDF Document (.pdf) .PDF
• Image File (.png) .PNG
• Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials
• Coordinates the processes of Due diligence, site contracting and purchase order preparation invoice tracking
• Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP)
• Ensures management of retain samples
• Ensure all clinical site personnel are trained to study protocol, procedures, and local regulations
• Ship investigational devices and performs device accountability, as applicable
• Prepare for and execute on-site qualification, study initiation, interim monitoring and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled
• Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines
• Communicate clearly with clinical sites
• Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies
• Knowledge of relevant medical device regulatory requirements
• Serve as a liaison for clinical trial agreement (CTA) and budget negotiations
• Ensure maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations
• Track progress of clinical studies with regard to budget, study milestones, and deadlines
• Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature required to support assigned product lines and related clinical studies, staying informed about applicable clinical landscapes and trends
• Participate in study audits, as applicable
• Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data
• Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support
• Participate in the CRO selection and management
• May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, edit specifications, and clinical study reports
• Assist with projection and management of clinical supplies
• Coordinate and/or participate in investigator meetings
• Responsible for updating study timelines and metrics
• Responsible for listing review and resolution of queries during database lock and in preparation of final study reports
• Participate in and/or chair meetings or conference calls with CROs, CRAs and cross-functional study teams
• Provide mentoring to CRAs and Clinical Trial Assistants (CTA’s)
• 5+ years of postgraduate pharmaceutical experience
• Experience with late stage drug development preferred
• Bachelor's Degree in a related field (e.g., biological, medical, public health, physical sciences, engineering) is required
• Ability to work effectively on a cross-functional team is desired
• Must have the functional and technical knowledge and skills to do the job at a high level of accomplishment
• Must possess ability to solves difficult problems with effective solutions
• Track clinical data, regulatory documents, patient enrollment, and data resolutions to assist the timely completion of clinical studies
• Assist in the creation of model informed consents, case report forms, instruction manuals, and monitoring tools
• Assure regulatory compliance of investigational sites with company SOP’s, FDA, and ICH guidelines
• Write visit reports and follow-up letters to investigators
• Set up files, archive study documentation, correspondence and completed case report forms
• Enhance professional growth and development through participation in education programs, current literature, in-service meetings and workshops
• Provide technical and administrative assistance to the clinical department
• Site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
• Involvement in Feasibilities and Start up of studies assigned
• Preparation of study documents and support in submissions
• Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans
• Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC)
• Bachelor’s degree in a relevant scientific discipline or equivalent
• At least 5 years of relevant clinical experience with at least 2 years in a CRA functional role in the pharmaceutical industry, with global study experience
• Able to perform assignments with general instructions
• Able to solve complex problems, prioritize multiple tasks, plan proactively and accomplish goals within project
• Assist in the preparation of study specific procedures and guidelines
• Responsible for all aspects of Site Management and Monitoring of clinical studies from initiation through close out, including onsite visits and remote monitoring
• Completion of visit reports and tracking in CTMS and other systems within requested timelines
• Working with a local and international project teams
• Responsible for data review as per project specifications
• Review and maintenance of regulatory documents as per study and local requirements
• Liaise between the sites and project teams and establish good communication and relationship
• Assist with training, mentoring, and development of new employees, co-monitoring
• Authorized to work in the US for any employer
• Be less than one hour from a major airport
• University degree in a science related field or are a certified health professional
• Degree in pharmacy, life science or related field
• Ability to mentor and train other monitors in a positive and effective manner
• Ability to evaluate medical research data and proficient knowledge of medical terminology
• Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines
• Participates in investigator meetings as necessary
• Consistently completes site monitoring reports
• For assigned sites/study(s), ensure successful protocol level execution of SMM deliverables involving start-up, execution, and close-out
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current
• Responsible for coaching and mentoring CRAs and providing input into their development
• May participate/lead in global/local task forces and initiatives
• Provide leadership in representing monitoring interests to the study conduct team
• Take a leadership role in developing monitoring organisation characterised by process standardisation, best practice sharing, and continuous improvement
• Provide training for new monitoring personnel and contribute to their performance appraisals, as appropriate
• Individual contributor who demonstrates diligent and self-motivated approach to working in an off-site and independent work environment
• Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CRFs and facilitate Institutional Review Board (IRB) submission, queries, and approval
• Experience developing tools and processes that increase measured efficiencies of the project
• BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
• Ability to use a variety of software programs (MS Office)
• Monitoring and/or site/ study management experience
• Demonstrated competence in standard business procedures (SOPs, Global Regulations)
• Experience in Oncology monitoring is preferred

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Clinical Research Associate

What does a professional in this career do.

A Clinical Research Associate is responsible for running clinical trials, usually for an organization undertaking pharmacological drug testing. Will ensure that trials adhere to good clinical practice guidelines for monitoring clinical trials.

Job Outlook

There were 324 Clinical Research Associate job postings in North Carolina in the past year and 8437 in the United States.

In combination with other careers in the Clinical Research Coordinator / Manager industry, which includes the Clinical Research Associate career, the following graph shows the number of people employed for each year since 2015:

Many new Clinical Research Associate jobs have salaries estimated to be in the following ranges, based on the requirements and responsibilities listed in job postings from the past year.

The average estimated salary in the United States for this career, based on job postings in the past year, is $113,501.

The average estimated salary in North Carolina for this career, based on job postings in the past year, is $120,116.

Percentiles represent the percentage that is lower than the value. For example, 25% of estimated salaries for Clinical Research Associate postings in the United States in the past year were lower than $85,531.

Education and Experience

Posted Clinical Research Associate jobs typically require the following level of education. The numbers below are based on job postings in the United States from the past year. Not all job postings list education requirements.

Posted Clinical Research Associate jobs typically require the following number of years of experience. The numbers below are based on job postings in the United States from the past year. Not all job postings list experience requirements.

Below are listings of the most common general and specialized skills Clinical Research Associate positions expect applicants to have as well as the most common skills that distinguish individuals from their peers. The percentage of job postings that specifically mention each skill is also listed.

Baseline Skills

A skill that is required across a broad range of occupations, including this one.

• Research (58.58%)
• Communication (45.89%)
• Management (45.13%)
• Detail Oriented (26.28%)
• Writing (24.04%)
• Microsoft Office (23.76%)
• Microsoft Excel (22.05%)
• Operations (21.89%)
• Coordinating (18.92%)
• Organizational Skills (18.88%)

Defining Skills

A core skill for this occupation, it occurs frequently in job postings.

• Clinical Research (93.14%)
• Auditing (22.17%)
• Clinical Trials (67.45%)
• Data Collection (23.32%)
• Case Report Forms (22.63%)
• Electronic Data Capture (EDC) (23.07%)
• Clinical Monitoring (15.48%)
• Good Clinical Practices (GCP) (43.87%)
• ICH Guidelines (12.07%)
• Institutional Review Board (IRB) (24.85%)

Necessary Skills

A skill that is requested frequently in this occupation but isn’t specific to it.

• Regulatory Documents (22.18%)
• Informed Consent (26.52%)
• Biotechnology (7.53%)
• Vital Signs (7.76%)
• Medical Devices (11.91%)
• Corrective And Preventive Action (CAPA) (4.76%)
• Reconciliation (8.09%)
• Regulatory Compliance (8.53%)
• Clinical Research Coordination (7.5%)
• Biology (12.8%)
• Data Quality (6.21%)
• Medical Records (14.47%)
• Data Entry (15.57%)
• Data Management (15.69%)
• Clinical Trial Management Systems (19.73%)
• Standard Operating Procedure (11.52%)
• Human Subject Research (7.98%)
• Life Sciences (9.75%)
• Remote Monitoring (5.26%)
• Medical Terminology (18.39%)
• Oncology (18.08%)
• Nursing (12%)
• Phlebotomy (9.61%)
• Project Management (13.16%)
• Research Experiences (6.47%)
• Drug Development (3.67%)
• Process Improvement (9.61%)
• Pharmaceuticals (13.8%)
• Effective Communication (4.08%)
• Regulatory Requirements (10.66%)

Distinguishing Skills

A skill that may distinguish a subset of the occupation.

• Clinical Investigations (3.72%)
• Trial Master File (9.34%)

Salary Boosting Skills

A professional who wishes to excel in this career path may consider developing the following highly valued skills. The percentage of job postings that specifically mention each skill is listed.

• Clinical Research (100%)

Alternative Job Titles

Sometimes employers post jobs with Clinical Research Associate skills but a different job title. Some common alternative job titles include:

• Clinical Research Assistant
• Clinical Trial Associate
• Oncology Clinical Research Associate
• Oncology Registered Nurse
• Clinical Research Study Assistant
• Regional Clinical Research Associate
• CRA Manager
• Clinical Research Fellow
• Clinical Trials Management Associate

Similar Occupations

If you are interested in exploring occupations with similar skills, you may want to research the following job titles. Note that we only list occupations that have at least one corresponding NC State Online and Distance Education program.

• Clinical Research Manager
• Clinical Trial Manager
• Clinical Research Director
• Clinical Research Coordinator
• Clinical Project Manager
• Natural Science Research Manager (General)
• Clinical Quality Manager

Common Employers

Here are the employers that have posted the most Clinical Research Associate jobs in the past year along with how many they have posted.

United States

• IQVIA (366)
• Johnson & Johnson (301)
• Actalent (276)
• Boston Children's Hospital (171)
• Grifols (165)
• Thermo Fisher Scientific (146)
• University of Pennsylvania (133)
• Labcorp (119)
• Beth Israel Lahey Health (107)

North Carolina

• East Carolina University (23)
• University of North Carolina (18)
• Actalent (15)
• Labcorp (14)
• Grifols (11)
• Novasyte (11)
• Thermo Fisher Scientific (9)
• North Carolina State University (9)
• Duke University (7)

NC State Programs Relevant to this Career

If you are interested in preparing for a career in this field, the following NC State Online and Distance Education programs offer a great place to start!

All wages, job posting statistics, employment trend projections, and information about skill desirability on this page represents historical data and does not guarantee future conditions. Data is provided by and downloaded regularly from Lightcast. For more information about how Lightcast gathers data and what it represents, see Lightcast Data: Basic Overview on Lightcast's Knowledge Base website.

Clinical Research Associate 1

The clinical research associate i will coordinate oncology research trials for the cancer center and associated satellite sites, primarily involving investigational medications and treatments, including early or late phase fda-regulated trials..

• Science and Medical Research
• Opening on: Jun 19 2024
• Cancer Center-Administration
• Research Foundation
• Clinical Research Associate I, E99

Job Summary:

The Clinical Research Associate I will coordinate Oncology research trials for the Cancer Center and associated satellite sites, primarily involving investigational medications and treatments, including early or late phase FDA-regulated trials. Ensure compliance with federal guidelines at every step. Interact and correspond with clinicians, sponsors, cooperative groups, Upstate's Institutional Review Board and regulatory agencies. Enroll, register and screen patients for Oncology clinical research trials; collect and submit clinical trial patient data. Perform various administrative duties, which may include proper collection and shipment of lab samples; regulatory upkeep and maintenance of clinical research study supplies.

Minimum Qualifications:

Bachelor's degree and 2 years related experience or equivalent combination of education and experience. Excellent oral and written communication skills and attention to detail. Ability to work both independently and within a team setting.

Preferred Qualifications:

SoCRA or ACRP certification or Oncology research experience also preferred.

Monday-Friday days

Message to Applicants:

Cover letters need to be on the same document as the resume for uploading purposes.

Recruitment Office: Human Resources

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability or other protected classes under State and Federal law.

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Clinical Research Coordinator Associate

🔍 school of medicine, stanford, california, united states.

Stanford University’s Department of Dermatology is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or manager/supervisor. The CRCA will support federal and non-federal clinical research studies including dermatological and investigative work in support of clinical trials, clinical research or biomedical research focusing on “bench to bedside” treatment.  

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies.  Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol.  Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects.  Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. 
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents.  Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. 
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits. 
• - Other duties may also be assigned

DESIRED QUALIFICATIONS:

• A Bachelor’s degree with an educational background in medicine and/or scientific field (biological sciences, social sciences, etc.)
• Strong oral and written communication skills
• Excellent attention to detail
• Proficiency in using computers, software, and web-based applications in a previous administrative setting

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience. 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. 

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. 
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS:  Occasional evening and weekend hours.

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide,  http://adminguide.stanford.edu .

The expected pay range for this position is $31.73 to $36.54 per hour.  Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at [email protected] . For all other inquiries, please submit a contact form .

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.

• Schedule: Full-time
• Job Code: 1013
• Employee Status: Regular
• Requisition ID: 103778
• Work Arrangement : Hybrid Eligible

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