clinical research certification

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Clinical Research Management Graduate Certificate

Jump start your career in the rapidly expanding field of clinical research

Ohio State’s online Clinical Research Management Graduate Certificate prepares healthcare professionals and students in any field to be leaders in the management of human subjects research. With this clinical research certificate, you’ll build a solid foundation in clinical research management and learn how to apply bioethical standards to the medical development and innovation of complex clinical research studies in the healthcare and biopharmaceutical environments.

Coursework for the online Clinical Research Management graduate certificate meets the major competencies established by the Joint Task Force Core Competencies for Clinical Research Professionals .

Ready for a bigger step?

If you choose to continue your education in clinical research, you may transfer 100% of the certificate’s course credits into Ohio State’s online  Master of Clinical Research degree program . Completion of the certificate program does not guarantee admission to the graduate program.

"There have been days at work when I think to myself, ‘I just learned about that last night’. It’s really exciting when you can actually see that come to be a part of your work day."

"Being able to apply everything I was working on for school immediately to my work was my favorite part of the program."

"I could not have faced so many obstacles without the support, strength and guidance from the faculty and staff. Even when times were tough, they believed in me, so I believed in me."

Frequently asked questions, is the program 100% online are any campus visits required.

This program can be completed 100% online with no campus visits required.

How flexible are online classes? What is my expected time commitment?

Online programs are Ohio State are designed for working professionals. The amount of credits you schedule will help determine how long it will take to complete your program. Your expected time commitment will vary based on your course load, but for every credit hour you are enrolled in, expect to complete three hours of work outside of class for studying or projects.

What does an online classroom look like?

Online courses at Ohio State are different from on-campus courses. We have designed online courses to take advantage of the benefits of the virtual experience, including connecting to outside people and ideas, presenting information, and engaging in discussions with your classmates and faculty.

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Calculate the cost of an online degree, and discover the best online degree for you and your budget.

Academic Calendar

Multiple start dates are offered during the academic calendar year for The Ohio State University College of Nursing’s online non-degree programs, so you can decide when to take the next step toward earning your Clinical Research Management Graduate Certificate.

Spring 2025

Application Deadline November 1, 2024

Term Start Date January 6, 2025

Summer 2025

Application Deadline March 1, 2025

Term Start Date May 6, 2025

Autumn 2025

Application Deadline June 18, 2025

Term Start Date August 26, 2025

Admission Criteria

To enroll in the online Clinical Research Management Graduate Certificate program, you must:

• Be a U.S. citizen or permanent resident
• Have a baccalaureate degree in a health related discipline
• Hold a minimum 3.0 cumulative GPA on a 4.0 scale in the last degree earned that is relevant to the program of study

The State Authorization Reciprocity Agreement, also known as  SARA , establishes uniform standards for distance education for all participating states and institutions. Ohio State joined SARA in 2015, which means Ohio State can offer most online and on-ground courses and programs in  SARA member states, districts and territories without seeking authorization in each state.

Career Outlook

This online graduate-level Clinical Research Management certificate will prepare you for your next steps with a broad foundation of knowledge and skills in human subjects’ research regulations, conduct, management and leadership.

Whether you’re looking to grow in your current career or make a career change altogether, Ohio State’s online programs can help you achieve your goals. Learn what the outlook is for your current or next career move using O*Net’s My Next Move tool.

The Clinical Research Management certificate includes 12 credits of graduate coursework, is offered 100% online and asynchronously and is designed to be able to be completed in three semesters. The curriculum meets the internationally recognized Joint Task Force for Clinical Trial Competency framework.

NURSING 7781 – Responsible Conduct of Research

Concepts and policies for the responsible conduct of research (RCR), Institutional Review Boards (IRB) and dissemination of findings will be introduced. 

MCR 7770 – Fundamentals of Medical Product Development and Regulation

Function of clinical research in medical product development and the regulatory process of new medical products. Laws and regulations concerning the development, testing, commercialization, and total product life cycle for medical products. Regulations governing the conduct of clinical research, including study sponsors, investigators, and Institutional Review Boards.

MCR 7405 – Clinical Research Study and Site Management

Fundamental principles of clinical research operations from study site selection to study closure from the perspective of sponsors and clinical research sites including an introduction to database design, management, quality assurance, and reporting for site and sponsor operations.

Understanding Online Course Types

As you research the right online program for you, you likely will come across the terms “asynchronous” and “synchronous.” Learn what these terms mean and how they’re important to consider when understanding how a program will fit into your life.

Program Faculty

The online courses in Ohio State’s Clinical Research Management Graduate Certificate are led by esteemed College of Nursing faculty. The Ohio State University College of Nursing is recognized by the National League for Nursing as a Center of Excellence for Creating Environments that Enhance Student Learning and Professional Development.

Jessica Fritter, MACPR, ACRP-CP

“There is a national demand for clinical research professionals. This certificate offers students a broad foundation in the management of human subjects research and credible educational credentials to break into the clinical research industry or advance their career.”

Carolynn Jones, DNP, MSPH, RN, FAAN

Amy Mackos, PhD

Testimonials

Find out how online learning has helped Ohio State students succeed.

“I could not have faced so many obstacles without the support, strength and guidance from the faculty and staff. Even when times were tough, they believed in me, so I believed in me.”

“Ohio State is a large institution with a lot of possibilities and opportunities. You will meet people who you can connect with and who will connect you with others.”

“being able to apply everything i was working on for school immediately to my work was my favorite part of the program.”, get started.

Speak with a knowledgeable Enrollment Advisor who can help answer your questions and explain different aspects of the more than 70 online degrees and certificates offered at Ohio State.

If you have a disability and experience difficulty accessing this content, contact our webmaster at  [email protected] or call 614-293-0387

• Join a Study

CITI Training

Ohio State requires all faculty, staff, trainees and students eligible to conduct research to be trained in the Responsible Conduct of Research (RCR) through the online Collaborative Institutional Training Initiative (CITI) RCR course every four years.  Depending on the grant type or funding, additional courses may be required.

Beginning in 2024, in alignment with federal requirements and the university’s shared values, this course must be completed every four years within 60 days of assignment and is required of:

• all those eligible to conduct research, including faculty, staff, trainees and students, regardless of funding source
• all those who have completed some form of RCR training but not the CITI RCR course

Required CITI training for CRPs at Ohio State includes:  Human Subject Protection (HSP), Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR).

Additional CITI training is also available for you through the Ohio State CITI:

• Social and Behavioral GCP Training
• CRC Foundations Course
• CRC Advanced Course
• Clinicaltrials.gov Protocol Registration and Results Summary Disclosure 

Login to CITI using Single Sign On (SSO) to access these courses .

Local Ohio State Departments may have additional training requirements based on your role.

• Weill Cornell Medicine

• Ambulatory Curriculum
• Categorical Track
• Primary Care Residents
• Resident Publications
• Primary Care Core Faculty
• Primary Care Graduates
• Medical Research Graduates
• 2024-25 Interns (PGY-1)
• 2024-25 Juniors (PGY-2)
• 2024-25 Seniors (PGY-3)
• International Applicants
• Simulation Program
• Resident Research
• Academic Time
• Quality Improvement and Patient Safety Experience
• Global Health Offerings
• Diversity and Inclusion
• Recent Graduates
• Chief Residents

Medical Research Track

The Medical Research Track (MRT) recruits and trains the next generation of leading physician-scientists. The accelerated 24-month MRT curriculum provides rigorous training in clinical medicine and allows trainees to reach subspecialty training (if desired) by their PGY-3 year to facilitate the establishment of an independent research-based career. Individuals who match into this program are also matched into the fellowship program of interest within the NYP/WCM Department of Medicine. As a "fast track" or research pathway resident, the full training commitment includes two additional years dedicated to research pursuits following subspecialty clinical training. Most MRT candidates have an extensive background in research, typically M.D./Ph.D. or similarly intensive training, and a specific scientific niche.

Weill Cornell Medicine’s renewed and unprecedented commitment to deliver groundbreaking discoveries offers unparalleled opportunities to current and future leaders in biomedical research. New scientific initiatives, housed in the 480,000 square foot Belfer Research Building, include interdisciplinary programs in the areas of cancer, cardiovascular disease, global health, metabolic health, inflammatory bowel disease, and more. An innovative set of partnerships between Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, Rockefeller University, and Takeda Pharmaceutical Company, termed the Tri-Institutional Therapeutics Discovery Institute, Inc. (Tri-I TDI) and Bridge Medicines, aim to expedite early-stage drug discovery into therapies for patients. Importantly, these initiatives have also been accompanied by parallel investments in trainee mentorship across all stages of their professional career paths, including a specific emphasis on physician-scientists.

Candidates with substantive training in, and a clearly defined commitment to, research are encouraged to apply. Please note: the Supplemental Application is required for consideration of this program.

Highlights of the Medical Research Track

• Dedicated advisors to facilitate exploration of research training opportunities within Weill Cornell Medical College, Rockefeller University, Memorial Sloan-Kettering Cancer Center, and the Hospital for Special Surgery
• Personalized career development sessions during outpatient practice time
• Medical Research Elective time for meeting faculty and learning about various laboratories' areas of focus
• Quarterly physician-scientist grand rounds, peer-group meetings among fellow physician-scientist trainees, and faculty career development activities

As prescribed by the research pathway of the  American Board of Internal Medicine (ABIM) , this track provides extensive, coordinated training in clinical sciences and basic biomedical research. The first two years are identical to the categorical residency program with the addition of career development workshops and personalized academic mentorship. In addition, candidates within the Medical Research Track are afforded elective time to explore the scientific offerings of the Tri-Institutional Community and future potential laboratory opportunities. By the PGY3 year of training, Medical Research residents are fully immersed in their clinical subspecialty field of choice, after which they commit to spend 80 percent of their time in full-time research training, and 20 percent of their time in clinical work.

Matched applicants are assured a fellowship position in their chosen subspecialty, or may choose to pursue fellowship elsewhere.

Internal Medicine Research Pathway

Subspecialty Research Pathway

* based on the subspecialty Taken from ABIM Policies and Procedures February 2011

Program Director

Kyu y. rhee, m.d., ph.d..

Program Director, Medical Research Track Professor of Medicine, Weill Cornell Medical College Attending Physician, NewYork-Presbyterian Hospital/Weill Cornell Medical Center Advisory Committee for the Medical Research Track

Advisory Committee for the Medical Research Track

Omar Abdel-Wahab, M.D.

Oncology, MSKCC

Laura Alonso, M.D.

Endocrinology, Diabetes & Metabolism

David Artis, Ph.D.

Jill Roberts Center for Inflammatory Bowel Disease ; Gastroenterology & Hepatology

Louis Bridges, M.D., Ph.D.

Rheumatology , HSS

Mary E. Charlson, M.D.

Clinical Epidemiology & Evaluative Sciences

Barry S. Coller, M.D.

Center for Clinical and Translational Science , Rockefeller

Ronald G. Crystal, M.D.

Genetic Medicine

Olivier Elemento, Ph.D.

Precision Medicine

Dan Fitzgerald, M.D.

Center for Global Health

Roy M. Gulick, M.D., M.P.H.

Infectious Diseases

Manuel Hidalgo, M.D., Ph.D.

Hematology & Medical Oncology

Julianne L. Imperato-McGinley, M.D.

Clinical and Translational Science Center ; Endocrinology, Diabetes & Metabolism

Gopakumar Iyer, M.D.

Philip kantoff, m.d..

Medical Oncology, MSKCC

Jonathan Weinsaft, M.D.

Steven lipkin, m.d., ph.d., randy longman, m.d., ph.d..

Gastroenterology & Hepatology ; Roberts Institute

Vicky Makker, M.D.

Ari m. melnick, m.d., carl f. nathan, m.d..

Microbiology & Immunology

Virginia Pascual, M.D.

Gale and Ira Drukier Institute for Children’s Health (Rheumatology)

Geoffrey Pitt, M.D., Ph.D.

Cardiovascular Research Institute

Shahin A. Rafii, M.D.

Regenerative Medicine

Joseph M. Scandura, M.D., Ph.D.

Manikkam suthanthiran, m.d..

Nephrology & Hypertension

Jedd D. Wolchok, M.D., Ph.D.

Sandra and Edward Meyer Cancer Center ; Hematology & Medical Oncology

Contact Information

Mailing address.

NewYork-Presbyterian Hospital/ Weill Cornell Medical Center Weill Department of Medicine  525 East 68th Street, Box 130 New York, NY 10065

Residency Office

530 East 70th Street, M-507 New York, NY 10021 Tel: (212) 746-4749 NYPCornell-IMResidency @med.cornell.edu

Education Events

Diversity news, education news.

• Transcripts
• Alumni Network

Scientist-Physicians Get Their Start at TouroCOM Montana

New medical scientist training program for aspiring physicians looking to combine clinical care and medical research begins at mclaughlin research institute.

Touro College of Osteopathic Medicine in Great Falls proudly announces the Medical Scientist Training Program (MSTP) launch. This innovative program, made possible by the generosity of Dr. Irving Weissman and in collaboration with the McLaughlin Research Institute, offers students an unparalleled opportunity to integrate medical research with clinical practice.

The MSTP is designed for students between their second and third years of Osteopathic Medical School (OMS). It offers a unique one-month intensive research experience during the summer, followed by comprehensive year-long immersion. The program supports future physician-scientists with a summer stipend for 2024, a monthly stipend during the immersion year, and full tuition coverage for their third and fourth years of medical school.

This summer, three TouroCOM Montana students participated in the MSTP, dedicating their time to cutting-edge research at the McLaughlin Research Institute (MRI). After their research period, each student developed a grant proposal outlining a subject they plan to study over the next year at MRI after completing their second year of medical school.

Ayeong (Jenny) Kim is a second-year student from Dublin, California, who studied neuroscience at Boston University, holds a bachelor's degree in neuroscience, and worked in clinical research as a clinical research assistant at Boston Children's Hospital/Harvard Medical School .  Jenny submitted her research proposal on "Elucidating the Inflammatory Mechanisms behind Central Sensitization and Chronic Pain," which will be the focus of her research at MRI following her second year of medical school.

"Working at the McLaughlin Research Institute has been an eye-opening experience," said Kim. "Collaborating with diverse researchers and engaging in both bench and clinical research has broadened my understanding of the intricate mechanisms underlying chronic pain. This program has highlighted the importance of integrating clinical insights with laboratory discoveries."

Another student researcher, Alexandria Reyes from Glendale, California, who earned a bachelor's degree in neuroscience from Scripps College and a Master of Biomedical Science from the California University of Science and Medicine, expressed her enthusiasm for the collaborative environment. "The early stages of research are truly fascinating. What has brought me the most joy is the team dynamic—Dr. Gunn's team, including the students from Touro and her research assistant, has made this transition into research so seamless. Everyone is incredibly knowledgeable, supportive, and welcoming."

Reyes submitted her research proposal, titled "Assessing the Potential of Rescuing SOX10 Dysfunction in Mouse Oligodendrocytes," which will be the focus of her research at MRI. "It's exciting to know that the research will eventually be published. Having your name on a published paper as a medical student is a huge accomplishment."

Matthew DiGiovanni from West Hempstead, NY, who double-majored in Biology and Political Science and earned a Master of Science from SUNY Stony Brook University, shared his background and aspirations. DiGiovanni’s research proposal, titled "Investigating the Potential Role of Extracellular Vesicles (EVs) in Treatment-Derived Inflammation, Focusing on Potential Changes in the Amount of or Contents of EVs from Non-Tumor Tissues and Implications in Cancer Progression," will be the focus of his year-long research at MRI. "My background is in research, though I took a three-year gap to work in higher education. I knew I wanted a research-focused career when I applied to medical school. The MSTP at Touro offered me the perfect opportunity to build my research experience and skills. I aim to match into a residency program emphasizing research, where I can continue developing as a clinical scientist."

"The MSTP at TouroCOM Montana deepens students' understanding of medical research and equips them with the skills necessary to bridge the gap between laboratory findings and clinical applications," said Dr. Tiffany Hensley-McBain, Associate Course Director at TouroCOM Montana. “This program underscores TouroCOM Montana's commitment to fostering the next generation of physician-scientists and allows our students to do incredible and valuable bench research.”

COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK

Clinical Research Coordinator

• Anesthesiology
• Columbia University Medical Center
• Opening on: Aug 28 2024
• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Salary Range: $62,400 - $78,600

Position Summary

A Clinical Research Coordinator position is available at the Moitra Laboratory in the Department of Anesthesiology, Division of Critical Care Medicine.  The Laboratory conducts a variety of clinical research studies, including studies of sepsis, cognitive dysfunction, delirium, mechanical ventilation, and complications after surgery. The successful candidate will work under the general supervision of the Director of the Laboratory, Dr. Vivek Moitra, and function as a team member with other research staff members.

Responsibilities

• Assists with screening and recruiting patients for clinical trials
• Provides basic explanation of study to potential participants and obtain informed consent from subjects
• Collects & organizes patient data from medical records, research subjects, physicians, etc.
• Maintains research records and databases
• Updates study forms per protocol
• Assists with conducting and documenting research subject study visits. Performs study procedures, which may include phlebotomy (if willing to take phlebotomy training).
• Maintain regulatory binders and QA/QC procedures
• Assists with interviewing study subjects
• Administers and scores questionnaires
• Ensure study regulatory submissions to the IRB, FDA, and regulatory bodies
• Performs administrative support duties or other duties as assigned.
• Takes responsibility for adherence to IRB approved protocols.
• Other duties as assigned.

Minimum Qualifications

Requires bachelor’s degree or equivalent in education and experience

Preferred Qualifications

While experience is helpful, we will welcome new graduates with relevant course/project work. Ability to use statistical software not required but a plus.

Other Requirements

• CITI Certification is required
• Intermediate Microsoft Office knowledge
• Have good organizational skills
• Ability to follow directions
• Have good communication skills
• Ability to write scientific reports and papers
• Willing to work off hours when needed per protocol
• Knowledge of clinical research protocols
• Ability to demonstrate respect and professionalism for subjects’ rights and individual needs
• Ability to work independently and as a team player
• Values a growth mindset and collaboration

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.

Commitment to Diversity 

Columbia university is dedicated to increasing diversity in its workforce, its student body, and its educational programs. achieving continued academic excellence and creating a vibrant university community require nothing less. in fulfilling its mission to advance diversity at the university, columbia seeks to hire, retain, and promote exceptionally talented individuals from diverse backgrounds.  , share this job.

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Clinical Research Training Fellow

Queen mary university of london - blizard institute.

About the Role

We are seeking to employ an ambitious and diligent clinical research training fellow to undertake a series of laboratory projects and clinical data analysis with supervision and training provided by members of the project team and by other facilities within Queen Mary, University of London and Barts Health NHS Trust. The fellowship will provide training in clinical and laboratory research to complement the candidate’s specialty training. The post holder will jointly report to the Lead and Deputy Lead of Genes & Health. The post holder will be provided training in in laboratory and clinical research governance, data management, and statistical analysis . They will also work closely with staff of various backgrounds to support our research activity across QMUL and Barts Health NHS Trust. The post holder will be assisted in identifying subjects, consenting, obtaining samples and transport of samples by a Research Nurse.

The post holder will provide specialist expertise to maximize research collaboration, effectiveness and output, whilst helping to ensure the successful delivery of clinical research benchmarks. They will be responsible for providing information and data on research activities, coordinating major grants applications and provide advice on administrative aspects of research from grant submission through to clinical trial delivery. With experience of working in a scientific or clinical research environment they will have a clear understanding of the processes, regulations and codes of practice associated with research. With strong analytical and problem solving capabilities, the successful applicant will coordinate others to increase their outputs, work to deadline and build strong working relationships. The post holder is expected to make sufficient progress with the project to enable a further funding bid for another year, leading to submission of a PhD .

About the School/Department/Institute/Project

The Blizard Institute was established in 2003 and is one of six Institutes within the Faculty of Medicine and Dentistry, QMUL. The Institute comprises approximately 360 staff based in four academic Centres and one Public Engagement Centre, and supports a combined total of c700 postgraduate research and taught students. The Institute aims to deliver excellence in all aspects of research, teaching and clinical service.

About Queen Mary

At Queen Mary University of London, we believe that a diversity of ideas helps us achieve the previously unthinkable.

Throughout our history, we’ve fostered social justice and improved lives through academic excellence. And we continue to live and breathe this spirit today, not because it’s simply ‘the right thing to do’ but for what it helps us achieve and the intellectual brilliance it delivers.

We continue to embrace diversity of thought and opinion in everything we do, in the belief that when views collide, disciplines interact, and perspectives intersect, truly original thought takes form.

Benefits We offer competitive salaries, access to a generous pension scheme, 30 days’ leave per annum (pro-rata for part-time/fixed-term), a season ticket loan scheme and access to a comprehensive range of personal and professional development opportunities. In addition, we offer a range of work life balance and family friendly, inclusive employment policies and flexible working arrangements. Queen Mary’s commitment to our diverse and inclusive community is embedded in our appointments processes. Reasonable adjustments will be made at each stage of the recruitment process for any candidate with a disability. We are open to considering applications from candidates wishing to work flexibly.

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Training Grants Research Admin

• Madison, Wisconsin
• SCHOOL OF MEDICINE AND PUBLIC HEALTH/DEPARTMENT OF SURGERY
• Sponsored Programs, Grants, and Contracts
• Partially Remote
• Staff-Full Time
• Staff-Part Time
• Opening at: Aug 30 2024 at 09:40 CDT
• Closing at: Sep 15 2024 at 23:55 CDT

Job Summary:

The Training Grants Research Administrator is part of the Office of Grant Administration in the Department of Surgery and reports to the Director of Surgery Sponsored Projects and Grants. This position serves as the coordinator for NIH-funded training grants as well as other extramurally funded research education grants held within the Department of Surgery, provides support to Program Directors in the execution of training grant requirements including recruitment, onboarding, reporting, and curriculum implementation. This position also interfaces with the Director(s) of Postdoctoral Research Training in the Department of Surgery to support the clinical residents in identifying potential funding, research training opportunities, and research mentors as well as assisting with grant submissions as needed. This includes: - Advising and assisting faculty and academic staff in developing and submitting research training-related grant applications, contract proposals, progress and final reports (and related budgets for all). - Keeping faculty, trainees, fellows, and appropriate staff apprised of status of grants, current contract or grant policies, regulations and guidelines made by granting agencies (especially NIH) and campus research offices. - Serving as a liaison with principal investigators (PIs) and granting agencies (including electronic research administration/ERA issues), University offices, etc. - Meeting with faculty and academic staff to identify research interests and to develop funding strategies and plan. - Recruitment, onboarding, and administrative support for research trainees in the Department of Surgery -Support the preparation of annual progress reports which includes collecting trainee progress information as well as updating information from current and past trainees -Working with HR related to trainee appointments and stipend levels -Preparing annual budgets for costs associated with research/academic development time -Supporting the further growth of the training grant portfolio in the Department of Surgery including data collection for grant submission and working with relevant internal workgroups/stakeholders. The person in this position will need to obtain a thorough knowledge of grant proposal development and the conduct of research and administration of research activity. The person in this position should be comfortable speaking in front of others and giving presentations.

Responsibilities:

• 20% Serves as a liaison and expert resource for researchers regarding the interpretation of policy and procedure related to overall sponsored project management
• 25% Works collaboratively with researchers to prepare non-technical materials for proposals, drafting contracts or agreements for review, and/or advising award setup
• 30% Leads researchers in the preparation and/or maintenance documentation, financial management, and/or reporting requirements related to sponsored grants, contracts, or agreements
• 5% May identify funding opportunities and disseminate to principal investigators
• 20% Assists in the development, coordination, and facilitation of training program requirements for multiple research training programs according to established research objectives in alignment with program design and strategic initiatives.

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred Bachelor's Degree

Qualifications:

Required Qualifications: -Experience in managing multiple projects and competing deadlines simultaneously -Experience in working independently and as part of a team Preferred Qualifications: -At least 3 years of substantial involvement or familiarity in research, sponsored programs administration either in a sponsoring or recipient organization, or the equivalent in a self-funding organization -Knowledge of NIH and other federal and university regulations for the conduct of research -Experience in medical or research setting -Experience working with trainees/learners -Strong understanding of budget development -Attention to detail and a high level of accuracy in tasks -Ability to interpret and analyze data and present findings in clear a clear and concise manner -Strong interpersonal skills, and excellent oral and written communication skills, with the ability to effectively communicate complex ideas and concepts -Proactive and problem-solving mindset

Full or Part Time: 80% - 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $56,112 ANNUAL (12 months) Depending on Qualifications The starting salary for the position is $56,112 but is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at ( https://hr.wisc.edu/benefits/ ).

Additional Information:

University sponsorship is not available for this position, including transfers of sponsorship. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants. If you are selected for this position you must provide proof of work authorization and eligibility to work.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience. You will also be asked to provide contact information for three (3) references, including your current/most recent supervisor during the application process. References will not be contacted without prior notice.

Samantha Connell [email protected] 608-265-5311 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Research Administrative Spec(SC029)

Department(s):

A53-MEDICAL SCHOOL/SURGERY/RESEARCH ADMIN

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

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• Six-Week Course for Students Offers Proactive Approach to Mental Health

New Wellness Program "Blue Steel: Building Resilient Trailblazers" Launches Soon

An innovative new program aims to ensure UNT Dallas students are mentally healthy, focused, and productive.

Blue Steel: Building Resilience in Trailblazers is a collaboration between The University of North Texas at Dallas (UNT Dallas) Counseling and Wellness Center and the Center for Depression Research and Clinical Care (CDRC) at The University of Texas Southwestern Medical Center in Dallas (UT Southwestern). The six-week course will run from Sept. 4 to Oct. 9 . Some participants may be able to receive academic credit.

“We are introducing the Blue Steel concept here at UNT Dallas as a proactive, preventative approach to depression and anxiety,” said Teresa Parnell, Director of the Counseling and Wellness Center . “Some of the stressors students experienced during and after the pandemic still exist. We want to promote mental health self-monitoring.”

Anxiety, stress, and depression grip many students, affecting not only their grades but also their relationships and performance in other areas, such as jobs and extracurricular activities. Whether you are a first-year student, a graduate student, or somewhere in between, the demands of the university experience can take a toll. Research shows that when resilience goes up, anxiety goes down.

The pilot program in 2023 resulted in rich data from more than 300 student-athletes at The University of Texas at Dallas (UTD).

“The Blue Steel mental health training was an enlightening experience, blending interactive sessions with practical exercises seamlessly to understand the importance of mental health practically,” said a UTD student who took the course last year. “I appreciate how it equipped me with techniques to maintain my mental well-being. Thanks to this training, I now make it a habit to reflect on my mental health regularly, fostering a healthier mindset.”

Since then, the program has agreed to collaborate with several other local colleges and universities – some with cohorts of student-athletes and some with general student body population – including UNT Dallas, Parker University, Texas A&M Caruth School of Hygiene, Texas Woman’s University, and The University of Texas at Arlington.

“We want to expand our reach to students who may not have support, help them take advocacy for themselves, add to their resilience and show them how to bounce back from adversity,” said Dr. Adrienne Mays, Supervisor of Learning at UT Southwestern’s CDRC. “We are especially concerned about first-generation students, students with families to support, and early college high school students.”

Citing an ongoing need for mental health education on campus and a chance to cooperate on research, Parnell and Mays collaborated to offer Blue Steel at UNT Dallas. Their goal is to teach students how to:

• Start a conversation, even with a stranger, especially if they are feeling overwhelmed
• Resolve conflict before it escalates
• Identify their emotions to affect outcomes
• Manage their time so that they can prioritize tasks and responsibilities
• Practice mindfulness and express optimism to help with focus and concentration
• Form connections with others, especially other students with whom they share things in common
• Reduce the stigma surrounding mental health

Blue Steel will be open to all UNT Dallas undergraduate and graduate students who want to enroll. It is an educational program—a class—that will meet in person on six consecutive Wednesdays with the same cohort and facilitators. Participants can choose either noon or 5:30 p.m. sessions. Click here to register.

Consistency is key and so is the data collected at the beginning and the end of each course cycle. It includes a survey asking students about their stress levels, how they handle their emotions, whether they proactively seek mental health support, and their use of drugs, alcohol, or other substances.

“We don’t judge them,” Mays said. “We teach them the brain is moldable and help them develop strategies for success.”

The survey feedback helps Blue Steel instructors fine-tune their programming, which means the training, support, and advice they share with students is relevant, timely and, most importantly, beneficial.

“I believe that the Blue Steel mental health training taught me more about how my inner thoughts work and how I can use them to my advantage. Furthermore, it was a good bonding experience for me and much of my team as we were able to laugh together at some of the silly things we did,” said another 2023 UT Dallas participant.

The impact of Blue Steel promises to grow beyond Dallas and the state of Texas. Even the State University of New York (SUNY, Plattsburgh) is embracing the program this fall. But for UNT Dallas, the priority is right here, close to home and close to the hearts and minds of our students. They face countless challenges and opportunities, and we will be here to help them every step of the way - they will be as strong as steel throughout their journey.

If you want more information or have questions about Blue Steel, a program designed to build resilient Trailblazers, contact the UNT Dallas Counseling and Wellness Center at 972 338 1816 , stop by Suite 1085 in the Student Center, or click here to complete a registration form.

About the CDRC:

Built on more than a quarter-century of research in mood disorders, the Center for Depression Research and Clinical Care (CDRC) was established within the Department of Psychiatry in 2015. Through its three-pronged approach towards ending suffering using depression research, dissemination, and training, the CDRC has established evidence-based programs that enhance the ability to treat depression. The CDRC always strives to build bridges to better mental health and well-being for communities in Texas and beyond; accomplishing this means addressing the needs and levels of community involvement that make success possible.

The CDRC has many exciting platforms for youth and families to participate in research that will help to understand resilience, depression, and substance use. If you would like to learn more about our research or participate in our programs, please complete our interest survey by scanning this QR code:

Foundations of Clinical Research

This Harvard Medical School six-month, application-based certificate program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career.

Associated Schools

Harvard Medical School

What you'll learn.

Understand and apply the foundational concepts of biostatistics and epidemiology

Develop a research question and formulate a testable hypothesis

Design and begin to implement a clinical research study

Cultivate the skills required to present a clinical research study

Critically evaluate the research findings in medical literature

Synthesize crucial statistical analyses using Stata software

Course description

The Foundations of Clinical Research program is rooted in the belief that clinical research training is critical to professional development in health care. Clinical research training not only creates potential independent investigators, but also enables clinicians to advance their careers through a greater understanding of research evidence. Designed to provide learners with the foundational knowledge and skill sets required to produce high-quality clinical research, our program will lay the fundamental groundwork in epidemiology and biostatistics required for a multifaceted career in clinical research.

The overarching goal of the Foundations of Clinical Research program is to equip the next generation of researchers with the skill sets essential to evaluating evidence, understanding biostatistics, and beginning their clinical research careers. Our aim is to ensure that learners develop a strong foundation in the design, implementation, analysis and interpretation of clinical research studies.

During the program, our innovative active learning approach emphasizes the traditional tutorial system with weekly live video tutorials, seminars and symposia anchored by 3 live intense weekend online workshops.  The Foundations of Clinical Research program’s six-month online curriculum emphasizes real-time skill-based learning. 

Participants will be eligible for Associate Alumni status upon successful completion of the program. Early tuition and need-based tuition reductions may be available.

Course Outline

Live Workshops

The interactive workshop curriculum will focus on hands-on skill development through active learning. To that end, the intensive schedule is designed to accelerate the growth of high-yield clinical research skills via individual and team-based workshop exercises. Students will be immersed in a dynamic learning environment that encourages collaboration and collegial networking with faculty and peers. 

Essential elements of the workshop include instruction and practical exercises in the core concepts of biostatistics, epidemiology and research question development, as well as critical assessment of the medical literature and practical training in statistical software using real-life datasets. In addition to providing training in mentorship, academic career development and leadership, we create a supportive and active learning environment where opportunities for knowledge retention and networking abound.

Live Symposia, Tutorials and Seminars

Symposia, tutorials and seminars are mandatory and will be delivered live online and organized according to eight specific clinical research topics. 

Eight 3-Hour Symposia

• Instruction on a specific clinical research topic (e.g., cohort study design and interpretation)
• In-depth discussion on a related epidemiology concept (e.g., odds ratio)
• Hands-on guidance for implementing the related analysis with statistical programming in Stata

Eight 1-Hour Tutorials

• Interpret and report on papers related to the specific clinical research topic

Eight 1-Hour Special-Topic Seminars

• The biostatistical and epidemiological concepts to specific clinical research topics with concrete examples

Assignments

All students will be expected to complete all assignments by the due dates. Assignments will be graded as either “pass” or “fail.”

Individual Assignment 1

Individual Research Question and Study Design

• Generate a novel research question in the evidence-based PICO format
• Receive expert faculty review

Individual Assignment 2

Design, Implement and Present an Original Abstract

• Design and implement a clinical research study based on a publicly available dataset
• Analyze and create data visualizations via a user-friendly R Shiny web app
• Write a formal 350-word abstract suitable for submission to an international conference
• Present a digital poster to faculty at Workshop 3

Online Lectures

Research Study Introduction 

• Designing a Clinical Research Study I–III
• Introduction to Evidence-Based Medicine, Systematic Review and Meta-Analysis
• Study Design 1 – Observational
• Study Design 2 – Randomized Controlled Trials
• Study Design 3 – Quasi-Experimental Studies
• Introduction to Biostatistics
• An Investigator’s Responsibility for Protection of Research Subjects
• How to Search PubMed
• Overview of Evidence-Based Medicine

Statistical Programming in Stata

• Loading Data
• Basic Programming Commands
• Data Cleansing
• Data Analytics I – Central Tendency
• Data Analytics II – Statistical Testing
• Data Analytics III – Regression Testing

Instructors

Jamie Robertson

Djøra Soeteman

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The 35th Annual Tumor Course reviews what is currently known about the tumor microenvironment, angiogenesis, metastasis, immunology, targeted therapies, metabolism, microbiome, and toxicity of immunotherapies.

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Clinical Research Certification

Clinical research training.

Our clinical research training program s have supported over 22,000 members in the past 7 years. CCRPS clinical research courses   are used by students at 1,200+ organizations, 6 governmental agenies, and 308 universities. Graduates of our clinical research certification have worked at over 1,600 different organizations including all major known CROs and 23% of our graduates have obtained managerial or higher level roles (2024 CCRPS LinkedIn Graduate Survey).  We offer personalized  clinical research career coaching  after clinical research course completion.  See April 2024 Graduate Case Studies .  

We have major clinical research training accreditations including Transcelerate Biopharma, ACCRE, and offer CME for physicians, nurses, and pharmacists through AMA, ANCC, and ACPE.  We are a candidate to become a federally-qualified institution with MSA-CESS. 

We are dedicated to our evidence-based and practice-based education philosophy to help you  learn clinical research  through simply great content unlike what you may have seen before. Clinical research training is self-paced, online, on-demand so you can start today and finish on the go with our mobile app. Speak to our 24/7 chat team or book with a course advisor to see which path is best for you. 

Speak to Course and Career Adviser Liz 

CCRPS Course Catalog

Advanced Clinical Research Coordinator Certification (ACRCC)

Advanced Clinical Research Coordinator Certification (ACRCC) - Triple-Accredited I 200 Hours I Online I Instant Enrollment I Dual ICH GCP w/ E6 and Advanced CRC Certification I 1+ Week Certification I Tuition with 2-4 Month Payment Plans

Advanced Clinical Research Associate Certification (ACRAC)

A Clinical Research Associate (CRA) assists in the monitoring and compliance of clinical trials. Clinical research associate certification is the leading, accredited, internationally-recognized CRA certification program available online.

Advanced International Pharmacovigilance and Argus Safety Certification (APVASC)

Pharmacovigilance Certification - Advanced Pharmacovigilance & Argus Safety Certification (APVASC) ACCRE Accredited I 180 Hours I Online I Instant Enrollment I I I Globally Recognized I 1 Wk Certification

Advanced ICH GCP Certification (AGCPC)

ICH GCP Certification - The most advanced ICH GCP training available I 50 Hours I On-Demand I Biopharma Recognized I 15+ Modules I Instant Enrollment I 1+ Day Certification I

Advanced Clinical Trial Assistant Certification (ACTAC)

Advanced Clinical Trials Assistant Certification (ACTAC) I Industry-Recognized CTA Training I 100 Hours I On-Demand I Accredited I 25+ Modules I GCP & E6 R2 Complaint I Instant Enrollment I 1+Wk Certification I

Advanced Clinical Research Project Manager Certification (ACRPMC)

Advanced Clinical Research Project Manager Certification provides 150 hours of advanced clinical trials and project management training for clinical research professionals looking to get into managerial roles in the industry.

Advanced Principal Investigator Physician Certification (APIPC)

Industry-Recognized PI Training I Modifiable courses based on prior experience I On-Demand I 17.5 CME I 100+ Modules (only review those you don't know) I GCP Complaint I Instant Enrollment I 1D-2 Wks for Certification

Advanced Physician Medical Monitor Certification (APMMC)

Advanced Physician Medical Monitor Certification (APMMC) Triple-Accredited I Written by Physicians I 17.5 CME AMA/ACCME I 250 Hours I 100+ Modules I GCP Complaint I Instant Enrollment I 2+Wk Certification I

CCRPS Clinical Research Community

CCRPS Reviews

CCRPS Graduate Case Studies April 2024

We’re thrilled to share more graduate case studies from graduates of our program. We value full transparency so full case study transcripts and videos will be available at your request. Please email our case study interviewer Courtney Fulkerson, a clinical research project manager herself, at [email protected] if you have any questions about this process.   

Need help deciding on a course or motivating yourself to finish your current course? We want to help you succeed. Speak with our course advisor in clinical research field herself, Liz. Schedule course and career advising session today (email [email protected] your resume before meeting). 

1. From IMG to Clinical Research Coordinator at Columbia University: “ This course not only met but exceeded my expectations with its thorough curriculum and insightful modules.” -Lisa-Pierre ( view full case study )

2. From IMG to Clinical Research Coordinator “The hands-on activities integrated throughout the course really helped solidify my understanding of complex concepts.” - Unber Mahmood ( case study summary )

3. Promoted to Senior Startup Specialist in Clinical Trials : “I appreciate how the course was structured—very interactive and engaging from start to finish.” - Justin Scott Brathwaite  ( transcript summary )

 4.  From Physical Therapist to Clinical Researcher:  “The in-depth content and expert instructors provided me with invaluable insights into the field.”  - Celia Moon ( case study summary )

5.  ICH GCP Usability Confidence :   “Thanks to this course, I feel more competent and confident in my role.” - Stephanie ( case study summary )

6.  Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek ( view full case study )

7.  From Clinical Research Receptionist to Certified Study Coordinator with CCRPS:   “I highly recommend this course for its comprehensive approach and practical applications.”  - Katie Decker ( view full case study ) 

8.  From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” - Aishwarya Sukumar  ( view full case study )

9.  Learning to Lead Safety Associate: "The course materials were clear, well-organized, and directly applicable to my work.” - Renata Noronha ( view full case study )

10.  From IMG to securing roles as a CRC, CRA, and now a project manager: “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak ( view full case study )

11.  From Physician to Confident Drug Safety Specialist:  “The course provided a robust foundation in the field, which was critical for my professional development.” - Rabiea Bilal ( view full case study )

12.  From plant biologist to clinical recruitment administrative coordinator : “This program is a gateway to extensive knowledge and skills in a supportive learning environment.”  -Olajumoke Owati  ( view full case study )

13.  From International PV Roles To North American Market Success: “The detailed modules prepared me excellently for real-world applications.” - John Vinil ( view full case study )

14.  From Educational Research to Clinical Trials Project Manager:   “I was able to immediately apply what I learned in the course to my job. ” - Rose Hyson ( view full case study )

15.  From Masters in Health Safety to Clinical Researcher:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

16.  ICH GCP made her more confident in research:  "this course just overall did a really good job going in depth, which I feel like wasn't just, it wasn't just covered just for the sake of covering content" -  Aastha Shah  (view full transcript)

17.     From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish.  Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

18.   From Clinical Research Intern to Regulatory Affairs Associate at UPenn: "I would say since then. I've completed this course. It's helped me get my job in regulatory affairs at a clinical research site." - Scott Boyle   (view SB full case study)

19.   From Clinical Research Monitor to Chief Medical Officer for CRO: " And CCRPS has a a complete, you have a really, really good approach to that. Because that is what we offer to our sponsors, quality and safety, because we are all physicians."   - Maria Lopez (full case study report pending)

18.   From International Pharmacist to Pharmacovigilance:   The pharmacist detailed challenges becoming a pharmacist in the US and choosing CCRPS for flexibility. Certification benefits were gaining clarity on research topics and standing out for clinical research roles.   - Ijeoma Osunwa   (full case study report pending)

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About the Clinical Trials Certificate Program

Clinical Trials are a key tool in the evaluation of new strategies for prevention and treatment of disease. This certificate program focuses primarily on the design and analysis of randomized clinical trials for evaluation of licensed and non-licensed medical products and other health interventions, the regulatory framework for the conduct and evaluation of data from clinical trials, and ethical principles for the conduct of clinical trials.

Educational Objectives

After completing the certificate, students will be able to:

• Summarize the history of clinical trials and describe the role they play in evaluation of health interventions;
• Explain the key differences, advantages and disadvantages of experimental versus observational study designs;
• Develop a protocol, consent statement, monitoring plan and data collection plan for a clinical trial;
• Review and critique manuscripts presenting the results of clinical trials using CONSORT guidelines; and 
• Explain the key ethical principles regarding the design, conduct and analysis of clinical trials

Curriculum for the Clinical Trials Certificate Program

Please visit our Academic Catalogue to see the full certificate curriculum requirements. Please also review the certificate completion requirements .

Admissions Requirements

Degree students.

The certificate program is open to graduate students currently enrolled in any division of the Johns Hopkins University, with the exception of MAS students, who are not eligible to apply until they have completed their primary degree program. 

Applying to the certificate program as a JHU graduate student:

Applicants who are already enrolled in graduate programs at JHU must submit a short letter of interest and CV/resumé to the Certificate Program Contact, and complete a Declaration of Intent form  prior to starting coursework. 

Eligible Start Terms :

Email Certificate Program Contact

Non-Degree Students

Students with at least a baccalaureate degree from an accredited college or university and a strong academic record are eligible for admission to this certificate program.

1st and 3rd

Applying to the certificate program as a non-degree student:

Applicants who are not currently enrolled in a graduate program at JHU are required to apply to certificate programs using SOPHAS Express . All non-degree applicants should review the general Certificates Admissions page for instructions on how to apply to a certificate program.

Prerequisites or special requirements

Application for Non-Degree Students

Information regarding the cost of tuition and fees can be found on the Bloomberg School's Certificate Programs Tuition page .

Financial Aid Eligibility: U.S. citizens and U.S. permanent residents enrolled in this certificate program may be eligible to apply for Title IV financial aid. Please contact the  JHU Office of Student Enrollment and Account Management (SEAM) for more information.

Questions about the program? We're happy to help.

Sponsoring Departments Epidemiology

Certificate Program Contact Sheila Small [email protected]

Faculty Sponsor Ann-Margret Ervin

• Exam Overview

SOCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so approved may use the title "Certified Clinical Research Professional" or "CCRP® (SOCRA)"

Background Information

Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions. Some clinical research professionals are MDs, while other are RNs; some may have a degree in medical technology, business administration, health information management, statistics, biology, teaching, or other areas. Every one of these backgrounds brings special areas of expertise to the field of clinical research. Each institution and discipline has unique requirements.

Despite the varied backgrounds and job descriptions, all clinical research professionals are guided by a common framework of regulations, guidelines and ethical principles in the conduct of clinical research. Therefore, the examination is designed to assess the applicant’s ability to apply the U.S. Code of Federal Regulations, ICH Guidelines, and ethical principles that guide the conduct of clinical research under the scope of GCP, highlighted in the standards of practice.

Examination Development

The Certification Examination has been developed by the SOCRA Certification Committee and SOCRA Certified Clinical Research Professionals (CCRPs®) who have demonstrated expertise in the development, management, and administration of clinical trials. These clinical research subject-matter experts (SMEs) come from diverse backgrounds and job descriptions to reflect the composition of SOCRA membership.

The test questions are designed to be straightforward and easily understood. The questions are reviewed by experts in test question development and SOCRA language representatives for fairness and readability.

The Certification Examination is evaluated and updated at least annually in order to assure that it is up-to-date and reflective of the current regulatory environment in which clinical trials are performed.

The certification exam content areas have been reviewed and validated through completion of a Job/Task Analysis. A copy of the Job / Task Analysis summary is available by request through the SOCRA administrative office.

Examination Validation

The exam is statistically and psychometrically validated by independent consultants. The Certification Committee evaluates the results from statistical/psychometric evaluations and updates the exam as needed.

The examination pass/fail score, or “cut score”, is statistically determined by a panel of experts using the "Modified Angoff Method." The “cut score” is validated after a review of the psychometric testing analysis.

Certification

• Program Overview
• CCRP Certification Quick Facts
• Definition of a Clinical Research Professional
• Certification Program Policies
• Removal of CCRP® Credential
• Verify Certification
• Candidate Eligibility
• 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

33RD ANNUAL CONFERENCE

ACHIEVING EXCELLENCE IN CLINICAL RESEARCH :

FORGING STRATEGIC COLLABORATIONS

September 27 to 29

COUNTDOWN TO ANNUAL CONFERENCE

Join us for expert-led sessions, interactive workshops, a peer-driven poster program, an engaging exhibit program and unparalleled networking opportunities!

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OFFICE OF CLINICAL RESEARCH EDUCATION AND COLLABORATION OUTREACH

• Clinical Research Education
• Funding Opportunities

Clinical Research Curriculum Certificate (CRCC) - NIH ONLY

The NIH Office of Clinical Research Education and Collaboration Outreach will issue a formal certificate to those successfully completing the required components of the following Clinical Research Curriculum. This program is currently only open to those employed at the NIH as staff, trainee or contractor.

The Clinical Research Curriculum Certificate (CRCC) program was developed for individuals engaged or interested in clinical or translational research. Participants will acquire in-depth knowledge of clinical trial design, ethical concerns and human subject protections, regulatory aspects of clinical research, and responsibilities of the clinical investigator.

To Receive a Clinical Research Curriculum Certificate

Please decide which type of certificate to apply for and have all documentation before submitting your application package. All requirements must have been completed within 2 years of your application date, unless stated otherwise.

Complete all of the following components of the CRCC:

• Introduction to the Principles and Practice of Clinical Research (IPPCR) Course certificate of completion
• Ethical and Regulatory Aspects of Clinical Research Course certificate of completion
• CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices
• Conducting Investigator-Initiated Studies According to FDA Regulations and GCP
• Investigator Obligations in FDA-Regulated Research
• Audits and Inspections of Clinical Trials
• Detecting and Evaluating Adverse Events
• Attendance at one virtual IRB meeting as a guest observer. View the OHSRP event calendar for IRB meetings and contact [email protected] to schedule your attendance.

All requirements for the CRCC Certificate and one of the options below:

• Principles of Clinical Pharmacology (PCP) Course certificate of completion or
• Successful completion of an FAES course in statistics or epidemiology in the last 5 years, verified by an unofficial transcript showing no withdrawal or drop of the course.

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ACRP Course Catalog

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CATALOG GROUPS:

• In-Person Training
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COMPETENCY:

• Clinical Trials Operations and GCPs
• Communication and Teamwork
• Data Management and Informatics
• Ethical and Participant Safety Considerations
• Leadership and Professionalism
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• Scientific Concepts and Research Design
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PRIMARY ROLE:

• CTMS Administrator
• Clinical Research Nurse
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• Clinical Research Scientist
• Clinical Data Coordinator
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For Individuals

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• Entry Level , Intermediate , Senior

Who’s in Charge When AI is Let Loose on Clinical Research?

September 13, 2024—Artificial intelligence (AI) has been touted as holding the solutions to a variety of vexing challenges in healthcare, but is it possible that there’s a downside to integrating what some might call an ungovernable technology into the clinical research arena? This live webinar ponders the issue of who’s making sure this power is being used to benefit everyone fairly.

Contact Hours

Action Steps for FDA Diversity Action Plans

September 25, 2024—In this live webinar, industry experts will offer examples of how diversity action plans vary among therapeutic areas — and why one size does not fit all. They also will explain why it’s important to incorporate action plans earlier in the clinical trial process, as well as consequences for failing to follow a submitted plan.

Facilitating Understanding in Informed Consent

October 9, 2024—Have you read the new draft Guidance from FDA for Sponsors, Investigators and IRBs on Key Information and Facilitating Informed Consent? Join this live webinar as our speaker discusses this guidance.

ACRP and the Academy Annual Membership Meeting

October 16, 2024—Join ACRP and the Academy leadership to explore highlights of ACRP’s year and what’s planned for 2025.

How to Make Soft Skills Your Superpower

With such an emphasis on the importance of soft skills, this webinar provided attendees with tools to assess the maturity of their soft skills. The speaker discussed developmental tasks attendees can employ to strengthen or enhance those that may be weak.

NIH Partnering with ACRP to Address Challenges Related to Implementing Trials (ACRP 2024 Recording)

Leaders at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognized that in recent years, a large proportion of National Institutes of Health (NIH) funded clinical trials have not achieved target enrollment within the allotted time or budget, and some have been terminated early for futility.¹ Based on a retrospective review of National Heart, Lung, and Blood Institute (NHLBI) funded trials, only 26% were successfully defined as achieving 100 percent enrollment in the target time allowed.

From Conflict to Collaboration: Enhancing Site and Sponsor/CRO Relationships

This webinar explored the perspectives and occasional conflicting interests of both parties, fostering mutual understanding. Representatives from each organization shared insights, real-life examples, and practical tools to overcome challenges, promoted productive collaboration, and contributed to clinical trial success

Deepening Diversity: LGBTQIA+ Diversity in Clinical Research

In this webinar, expert panelists discussed how sponsors can smooth the LGBTQIA+ patient journey for clinical trials, starting with gender-neutral protocols, making trial communication more inclusive, the FDA’s draft guidance on diversity plans and data collection, and the roles that sites/investigators can play.

Merck Journeys: Career Conversations within Clinical Research

Discover the exciting world of clinical research at Merck during this informative event. Hear from professionals from Clinical Data Management, Clinical Science and Study Management, and Clinical Research Associate roles as they discuss their careers, the industry, and their experiences at Merck.

The Future of Home Health Care in Clinical Trials

This session provided insights into the presenters experience with home health visits to-date and prompted site and investigator attendees to understand what works and doesn’t work for sites when offered home health options in trial protocols.

ACRP 2024 Full Program – Replay

A replay package of 86 on-demand session recordings and presentation slides from the ACRP 2024 Conference, May 3 – 6, Anaheim, California. It includes content from the six educational tracks, the Signature Series sessions, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2027.

ACRP 2024 Study & Site Management – Replay

This package is a replay of 26 on-demand session recordings and presentation slides from the Study & Site Management Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Learn practical, proven ways to maximize study and site performance.

ACRP 2024 Regulatory & Compliance – Replay

This package is a replay of 13 on-demand session recordings and presentation slides from the Regulatory & Compliance Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Hear tips and strategies to mitigate risk and keep your studies in compliance.

ACRP 2024 Clinical Trial Design – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Clinical Trial Design Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Explore the fundamental considerations for effective clinical trial design.

ACRP 2024 Leadership & Professionalism – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Leadership & Professionalism Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Get the insights you need to advance your career and grow as a leader.

ACRP 2024 Workforce Development – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Understand the workforce landscape and gain strategies to build smarter teams.

ACRP 2024 Technology & Future Trends – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Gain strategies to optimize technology and move your studies into the future.

Improving the Understanding of Informed Consent Among Vulnerable Populations

This webinar addressed practical ways stakeholders in research can help improve the creation of ICFs and better the overall process to ensure patients have a fuller understanding of the risks, commitment, and cost of agreeing to participate in a clinical trial.

Employee Development and Succession Planning

This webinar targets site and organizational leaders with the kinds of details they need to pay attention to in order to develop the framework for an employee development program which will support succession planning.

Intro to In Vitro Diagnostics (IVDs): The Path to Working Together Globally and More Efficiently

This webinar addressed the pressing need for standardized regulatory practices in the field. With advancements in in-vitro diagnostics (IVD), an increasingly interconnected global healthcare landscape, and the growing demand for precise diagnostics, the need for harmonized regulations is paramount.

Clinical Trial Process History and Overview

This webinar covered phases of drug development, the history of regulatory development of human research protection, various types of research study designs, conducting a clinical trial, and generic name and trade name of the medicine.

Efficiency Unleashed: Optimizing Clinical Research Onboarding and Education

Clinical trial professionals with an interest or role in the onboarding and education of new staff can learn valuable best practices from the steps taken, barriers encountered, and resources available during one clinical trial site’s journey toward realizing its goal for optimal efficiency.

Building Your Team Through Transformational Leadership in Clinical Research

This webinar challenged attendees to self-reflect on their own leadership practices and how those might have been in need of transformation

ISO 14155 and FDA Requirements – Trials Conducted at the Research Site

This program explored medical devices and investigational medical devices.

Unlearn to Learn: The Evolution of Clinical Research/Trial Training

This session discussed the current way clinical trial training is implemented and ways that it could potentially be done more effectively and efficiently by industry stakeholders.

A Review of Medical Record Data Extraction and Adverse Event Reporting

This informative session explores some of the tools of the clinical research trade including data extraction and adverse event reporting.

Broadening Your Approach to Trial Diversity on a Global Scale

This live webinar explored diversity through a global lens by tapping into the perspectives of industry leaders who addressed how we can broaden access to a wide range of underrepresented groups, including those who possess attributes linked to troubling and challenging health disparities.

Merck Journeys: Elevating your Career within Clinical Research

This webinar offered a unique opportunity to learn about the rewarding career paths in CSSM. Experienced professionals from Merck shared insights into the innovative clinical research strategies, and discussed how your transferable skills can be leveraged in this field.

ACRP Annual Membership Meeting

ACRP and The Academy leadership joined together to explore highlights of the past year and see what was planned for 2024. Attendees heard how ACRP is working for them and the clinical research profession.

Investigator-Initiated Trial Tips and Tricks

This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.

Good Clinical Practice (GCP) Simulation Renewal

The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

Home Study: August 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Introduction to Decentralized Clinical Trials (DCTs)

Gain the foundational knowledge clinical research professionals need to implement digital health components in clinical trials.

Investigational Drug Services Pharmacists: What They Wish You Knew

How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.

How Do IRBs Review Virtual Trial Technology?

How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.

ACRP 2023 Full Program – Replay

A replay package of 62 on-demand session recordings and presentation slides from the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. It includes content from the five educational tracks, the Signature Series sessions, Rapid-Fire session, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2026.

ACRP 2023 Workforce Development – Replay

This package is a replay of 8 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Understand the workforce landscape and gain strategies to build smarter teams.

ACRP 2023 Technology & Future Trends – Replay

This package is a replay of 7 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Gain strategies to optimize technology and move your studies into the future.

ACRP 2023 Leadership & Career Growth – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Leadership & Career Growth Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Get the insights you need to advance your career and grow as a leader.

ACRP 2023 Regulatory Trends & Compliance – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Regulatory Trends & Compliance Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Hear tips and strategies to mitigate risk and keep your studies in compliance.

ACRP 2023 Study Management & Conduct – Replay

This package is a replay of 17 on-demand session recordings and presentation slides from the Study Management & Conduct Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Learn practical, proven ways to maximize study and site performance.

2022 Site Perceptions Industry Survey Results: Actionable Insights for Sites, Sponsors, and CROs

Site leaders often feel their voices are not heard during the planning and conduct of sponsored clinical trials, while sponsors and contract research organization representatives feel at odds struggling to enhance relationships with those same sites. This webinar focuses on the results of an industry survey conducted by the Tufts Center for the Study of Drug Development on site perceptions, preparedness, and experiences with new clinical research execution solutions, and offers lessons learned on how you can improve site sustainability and lead more effective collaborations.

I Need a Mentor: Where Do I Start?

Career success shouldn’t be measured solely by how far one is able to climb the organizational ladder, especially when reaching career goals depends on so much more than mere effort. In an environment where achievement may rely less on “what you know” than on “who you know,” identifying the right individuals to be part of your knowledge bank and support squad can become crucial.

Building a More Equitable Future Together by Driving Inclusion in Clinical Trials

This webinar targets professionals across the clinical trial ecosystem with best practices learned about taking collective action to drive improvements focused on diversity, equity, and inclusion (DEI) issues. You will learn about building trust within historically underrepresented racial and ethnic minority communities, making clinical trials inclusive by design, and fostering partnership to address DEI-related issues in an integrated and sustainable manner.

Building Clinical Trial Diversity Action Plans for the Future, Now

Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.

A Review of ICH E8 (R1) General Considerations for Clinical Trials

The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.

Achieving Global Health Equity Through More Diverse and Inclusive Trials

Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.

2022 ACRP/Academy Annual Membership Meeting

Join ACRP/Academy leadership to explore highlights of ACRP’s year and what’s planned for 2023 in the areas of membership, certification, and finances.

Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 1): Theoretical Foundations and Core Competencies of Self-Leadership

Learn how to use self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world.

Ensuring Quality in Fast Enrolling Trials

Are new trials coming at you with break-neck speed? This webinar reviews a case study from a fast-enrolling trial and offers strategies for maintaining high quality standards and recognizing and mitigating the risks of accelerated enrollment.

Webinar—Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 2)

Learn even more about using self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world, in part two of this webinar. 

In the DCT Journey, Every Cloud Has a Silver Lining

This webinar focuses on some of the advantages and takeaways learned so far from the introduction, implementation, and adoption of decentralized clinical trials (DCTs). Panelists explore how they operationalized best practices in the areas of budgeting, contract language, remote monitoring practices, virtual visits, and more.

ICH E9: A Review and a Look Into the Addendum (R1)

Dive into an overview of both the ICH E9 Guideline on Statistical Principles for Clinical Trials from the International Council for Harmonization and the ICH E9(R1) Addendum, exploring how clinical trials are based on statistical principles and how treatment effects are measured.

Understanding the Role of DMCs and EACs in Research Oversight

Take a deep dive into the roles and functions of Data Monitoring Committees/Data Safety Monitoring Boards (DMCs/DSMBs) and Endpoint Adjudication Committees/Clinical Events Committees (EACs/CECs) in the lifecycle of clinical trials. These committees are increasingly tasked with providing independent, expert evaluations of clinical trial events and unbiased adjudications to determine if the definitions of certain clinical trial events have been met.

Everything You Need to Know About Holding an IND

This webinar provides a review of the purpose of and expectations set for holding an Investigational New Drug (IND) application through the U.S. Food and Drug Administration, explores common IND-related errors and how to avoid them, and outlines related requirements found in 21 CFR 312 of the Code of Federal Regulations for IND maintenance.

Deconstruct Your Clinical Trial to Plan a Positive Outcome: Effective Planning and Communication Strategies

This webinar examines the communication of intent and expectations to stakeholders in clinical trials to minimize risk and gain fluidity in operations, along with key elements behind planning a clinical trial and best practices for budgeting a study.

Streamline Your Clinical Research Organization’s Processes with End-to-End Promotions

Presenting a discussion on how consolidating the processes involved in the phases of drug discovery, pre-clinical research, clinical trials, and post-approval expectations on a single platform drives efficiencies, margin improvements, and real-time collaborations internally and externally. The result is better top- and bottom-line financial performance and consistency in process outcomes during trial execution.

Best of ACRP 2022

The “Best of ACRP 2022” package offers recordings from 25 of the most popular sessions from our most recent in-person event, along with seven techXpo sessions, presented by a variety of clinical research service providers.

Eliminating Barriers to Careers in Clinical Research

A perfect storm of negative trends is putting immense pressure on entry-level hiring, retention, and overall satisfaction and growth in the clinical research workforce. This webinar focuses on recognizing and overcoming the challenges that are unnecessary barriers to greater participation in the workforce by promising talent from a range of backgrounds and experiences.

The New Work Life Balance in Clinical Research

There’s no denying that “work as usual” has gone out the window in recent years–in the clinical research workforce as well as in most other settings. This webinar explores strategies for juggling a career in clinical research and your personal life in the “new normal,” including in the arenas of excelling at time management in the office and at home, reaching an ideal work/life balance, and acquiring tools to help make your goals a reality.

Investigative Site Diversity: Tufts CSDD Study on Staff Diversity at Clinical Research Sites

In this webinar, the Tufts Center for the Study of Drug Development team shares survey results on staff diversity at clinical research sites, with an emphasis on the impact diversity has on site performance and its practical implications, the major factors noted for diversity-related success and their associated barriers, and the relationship between site diversity and patient diversity.

The Push for Technology: A Discussion of Implementation Struggles, Strategies, and Lessons Learned

This webinar features a panel discussion on how the pandemic pushed the implementation of new technologies for clinical trials, with a site-centric focus on the struggles overcome and lessons learned, along with the impact on the workforce and how we all may want to prepare for the future.

Best Practices for Communicating Benefit, Risk, and Uncertainty in Medical Device Clinical Trials

This webinar focuses on how research participants cannot make an informed decision to participate in a clinical trial without clear communications from the research professionals supporting the trial. Evidence-based practices are covered to help you conduct patient education and informed consent tied to the benefits, risks, uncertainties, and patient preferences for using new medical technologies.

Using Agile Strategies to Solve Challenges in Research Operations

This webinar looks at how being agile in research settings is becoming a key performance indicator that partners and sponsors are seeking and expecting from sites, with a focus on techniques and strategies you can use to address and solve administrative and operational challenges at a faster rate via pragmatic and thoughtful “big swings of bold.”

Clinical Research Staffing Reprioritizations and Resourcing Strategies

This webinar presents lessons learned from a survey on the impacts of the pandemic on staffing at research sites, and discusses implications for the future of clinical research workflows from the current shift to remote operations. When should you look for help or change your staffing approach?

The Future of DCTs: Are You Prepared?

This webinar is tailored for research professionals in sponsor, contract research organization, and study site settings who wonder how to embrace the challenges and benefits of decentralized clinical trials (DCTs), and includes a practical guide for what DCTs really are, how there is no going back, and how it is up to the research professional to adapt to change.

Research Ready: Leveraging Technology in the New Research Landscape

Join Advarra experts in a discussion on how to leverage technology in the new research landscape

Working with Site-Based Paperless Solutions and Ensuring Audit Readiness

Join RealTime experts for an overview of site-based electronic systems that the research industry is rapidly adopting.

Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives

Join experts from WCG Velos and the University of Kansas Medical Center to learn top practices and processes sites follow to meet compliance standards.

Good Clinical Practice (GCP) Simulation

Informed consent simulation.

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

ACRP Clinical Research Knowledge Assessment™ (CRKA)

Whether you’re an emerging professional looking to demonstrate your foundational knowledge to prospective employers or an organizational leader looking for an efficient, effective way to vet new hires, ACRP’s new Entry-Level Knowledge Assessment (ELKA) is for you.

Certified Quality Manager Training

Increase your influence and expand your career opportunities by validating your commitment to quality. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites.

• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Clinical Trial Monitoring Basics

Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

• Entry Level , Intermediate
• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, , Trainer

Ethics and Human Subject Protection: A Refresher Course

When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.

• Investigator,

Investigator Responsibilities

Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.

Improving Recruitment, Accrual, and Retention in Clinical Trials

Explore best practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity. Included tools will help you assess how to better communicate with potential participants and begin a critical reflection of your own skills and organizational practices.

Trial Feasibility and Selection: Their Impact on Accrual

Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. This eLearning course will discuss how the menu or portfolio of studies offered at a site has an important impact on accrual and how research professionals can become part of the process.

• CRC, CRN, Investigator, PR, RM

Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.

Using Metrics to Improve Subject Recruitment and Retention

Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring.

• BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Clinical Trials

Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.

• Intermediate , Senior

Site Quality Management Tools: SOPs, Metrics and Training

Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.

• BCO, CDC, CRC, CRN, CRS, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.

Mastering the Event Reporting Cycle: Understanding Adverse Events (AEs)

Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

• BCO, BD, CDC, CRC, CRN, CRS, DM, Investigator, MA, MD, MRS, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review

Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.

Statistical Principles for Clinical Trials: Overview of ICH E9

Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.

• BCO, CRC, CRN, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, RTA, SSSU, Trainer

Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

An essential course for all clinical research professionals involved in the clinical trial agreement and/or budget process for industry-initiated trials.

Risk-Based Decisions: Key Skills for Ensuring Quality Control

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.

• CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

ICH Gap Analysis

Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.

• Investigator, MCRA, PMs

Form FDA 1572: Get it Right the First Time

The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.

Ethics and Human Subject Protection: A Comprehensive Introduction

Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. This eLearning course provides in-depth training on the importance of ethical conduct in clinical trials involving human subjects.

The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.

• BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Trainer

eResearch: Managing Clinical Trials in an Electronic Environment

Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.