Discover Excellence in Clinical Research Leadership
100% Online
14 Months*
The George Washington University (GW) online Clinical Research Administration (CRA) Graduate Certificate Program will prepare you to be a strategic leader who drives success for organizations in the clinical research industry. This graduate certificate program will strengthen your career prospects while developing Clinical Research Administration skills and a Regulatory Affairs knowledge base for more diverse professional opportunities.
*The total number of credits and duration of the program depend on the number of transferred credits
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Accreditation and Rankings
- GW is accredited by the Middle States Commission on Higher Education
- #62 Best National University*
- #13 Best Online Bachelor's Programs*
- #7 Best Online Programs for Veterans*
* The U.S. News & World Report – 2024 Rankings
Program Highlights
- 100% online, no visits to campus required
- The program requires 12 total credits and can be finished in 14 months
- All credits can be transferred into the MSHS in Regulatory Affairs and Clinical Research Leadership
Program Outcomes
Upon completion of the online CRA graduate certificate, you’ll be able to:
- REGULATIONS AND FUNDAMENTALS OF CLINICAL DEVELOPMENT: Explain and assemble the components of clinical and regulatory plans for the development of investigational therapeutics. Ensure components adhere to domestic and international laws, regulations, and pre- and post-approval requirements.
- LEADERSHIP AND STRATEGY: Appraise and apply strategies to lead interdisciplinary teams to ensure successful pharmaceutical/medical device product development, regulatory approvals, and marketing activities.
- QUALITY AND COMPLIANCE: Describe and select strategies to ensure clinical trial diversity, ethical conduct, patient safety, data integrity, and compliance with domestic and international laws and regulations when developing new therapeutics.
- BUSINESS ACUMEN: Identify and evaluate elements of the therapeutic product lifecycle to address the evolving global legal, clinical, and regulatory requirements in the healthcare industry.
Who Is the Ideal Student for This Program?
The online CRA graduate certificate program is ideal for working clinical research professionals, or those in a related field, who wish to increase their knowledge of drug development, clinical trial conduct, monitoring, regulatory affairs, and the business, ethical, and legal perspectives of the clinical research industry.
Career Outlook
Designed to answer the growing need for clinical research jobs and focusing on strategic leadership in the real world, the online CRA certification program offers diversity when it comes to job outlook. The program will prepare you for some of the highest-level positions within clinical research organizations.
Clinical research director positions have an average annual earning potential of $116,7421, and clinical data manager positions have an average annual earning potential of $74,7972. These are just a few of the high-paying and in-demand careers in clinical research that you can pursue with a CRA master’s degree.
Graduates of this clinical research graduate certificate program are prepared to lead health care organizations in the following roles:
- Clinical operations manager/director
- Clinical project manager/director
- Clinical research manager/director
- Clinical study manager/director
- Clinical trial manager/director
- Drug safety manager/director
- Institutional review board member
Admission Requirements
To apply for this clinical research administration graduate certificate program, you’ll need:
- Completed application
- 3.0 GPA or above on a 4.0 scale
- Bachelor’s degree
- Resume/CV
- Personal statement
- Two letters of recommendation
- Previous work experience: regulatory affairs, clinical research or health care related experience preferred
Tuition Details
The CRA graduate certificate program at GW consists of 12 credit hours. Please find the cost per credit hour and total estimated program costs here.
Note: Tuition rates are subject to change and additional fees may vary by program.
Meet the Program Director
GW’s experienced faculty provide you with the rich, practical knowledge and support needed for you to succeed in the program and in your career.
Kathleen Thoma, EdD, CCRP, CPH
- Full Bio
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Dr. Thoma is the Program Director for the BSHS in Clinical Research Administration Program, the Dual Degree Clinical Research Administration Programs, and the Graduate Certificate in Clinical Research Administration Program. She is also the Assistant Program Director for the MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration Program, and an Assistant Professor in the Department of Clinical Research and Leadership. She has over 20 years of experience in clinical research, health services research and educational research. Before coming to the George Washington University School of Medicine and Health Sciences, she was the director of research and a clinical research specialist at the University of Florida Center for HIV/AIDS Research, Education and Service (UF CARES) where she managed many NIH and industry-sponsored clinical trials during her tenure. Her particular expertise involved working with NIH-sponsored trials through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and the Pediatric HIV/AIDS Cohort Study (PHACS) network. She has also held positions as research project manager for the Pediatric Research in Office Settings (PROS) Network at the American Academy of Pediatrics, director of educational research at Florida State College at Jacksonville, and research project coordinator at the University of Illinois at Chicago’s College of Medicine/School of Public Health. She earned a doctorate in Educational Leadership with a cognate in Public Health from the University of North Florida. She is a Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) and holds the Certified in Public Health (CPH) credential from the National Board of Public Health Examiners. Her research interests include patient engagement and centricity in clinical trials, increasing diversity and inclusion in clinical trials, health literacy, health disparities and the social determinants of health, health equity, and distance education in the health sciences.
Sources:
- Payscale (2022 January 12). Average Clinical Research Director Salary. Retrieved February 15, 2022, from https://www.payscale.com/research/US/Job=Clinical_Research_Director/Salary.
- Payscale (2022 January 26). Average Clinical Data Manager Salary. Retrieved February 15, 2022, from https://www.payscale.com/research/US/Job=Clinical_Data_Manager/Salary.
Curriculum Details
12 TOTAL CREDITS REQUIRED
The curriculum for this graduate certificate program offers advanced CRA coursework for students and requires the completion of 9 core credit hours and a 3-credit-hour elective.
Students in the Graduate Certificate in Clinical Research Administration (CRA) program (100% online) must successfully complete 9 core credit hours and a 3-credit-hour elective.
All credit hours from the clinical research administration graduate certificate program are transferable to the MSHS, so students can seamlessly matriculate into the new Master’s in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration (RCR) program.
CORE
- RCR 6201 Introduction to Global Regulatory Affairs and Clinical Research (3)
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Foundation of regulatory affairs and clinical research in therapeutic development in U.S., EU and Japan. Roles in developing products, navigating the regulatory review and approval process, and maintaining products on the market.
- RCR 6102 Regulatory Strategy in the Development of Therapeutics (3)
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Overview of therapeutic development through the analyses of the critical elements of the product lifecycle, assessment of non-clinical and clinical data, and integration of strategic business needs and post-marketing efforts in planning regulatory strategy. Prerequisite: RCR 6201
- CRA 6204 The Clinical Research Industry (3)
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Integration of project management principles, decision making models, cross-cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.
ELECTIVE - SELECT ONE
- CRA 6203 Partnerships with Human Subjects (3)
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This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.
- CRA 6209 Quality and Risk Management (3)
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This course explores how to manage risk and safety assessments to ensure quality in clinical research.
- CRA 6211 Monitoring, Auditing & Oversights in Clinical Research (3)
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Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.
- RAFF 6203 Regulatory Strategy in the Development of Devices and Diagnostics (3)
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Development and evaluation of the regulatory affairs strategies that support device and diagnostics development. Research science, study design, master file, risk/benefit analyses, product specifications and milestone identification, IDE, 510K, PMA. Prerequisites: RCR 6201.
- RCR 6206 International Regulatory Affairs and Clinical Research (3)
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This course explores international regulatory requirements for the development and approval of new pharmaceutical products around the world. Prerequisite: RCR 6201.
Key Dates
|
Summer 2025 |
Fall 2024 |
Spring 2025 |
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| Application Deadline |
March 20, 2025 (Open) |
July 20, 2024 (Closed) |
December 1, 2024 (Open) |
Admissions Requirements
To apply for the Graduate Certificate in Clinical Research Administration program (100% online), you’ll need:
- Completed application
- 3.0 GPA or above on a 4.0 scale
- Bachelor’s degree from an accredited college or university
- Resume/CV
- Personal statement: Applicants must include a 250–500 word essay describing your reasons for undertaking study at GW, your academic objectives, career goals, and related qualifications including collegiate, professional, and community activities relevant to your program of interest. Include any substantial accomplishments not already mentioned on the application form.
- Two letters of recommendation
- Letters of recommendation should be from: Academic instructors who can strongly attest to your academic ability, and/or
- Individuals who served in a supervisory capacity for you, and who can strongly attest to your work ethic.
- The recommender cannot be a family member or friend.
- Recommender will submit a letter on letterhead with a signature and credentials/contact information via the application portal.
- Application fee: A non-refundable application fee of $80 is required. The application fee is waived for active-duty U.S. military, current GW students, degree-holding GW alumni, current McNair Program Scholars, and graduates of minority-serving institutions (MSI).
- Official transcripts from every college and university attended. All non-U.S. transcripts (including those in English) must be evaluated by an accredited foreign credential agency. Please find the list of member organizations here: https://www.naces.org/members.
- Previous work experience: Regulatory affairs, clinical research or health care related experience preferred.
NOTE: This program is authorized, exempt, or not subject to state regulatory compliance and may enroll students from all 50 states, U.S. territories and the District of Columbia.
International Students
International students should check with individual programs regarding eligibility for visa sponsorship. Generally, online and hybrid programs are not eligible for student visa sponsorship from GW. This would include transfer students from any other institution with an existing visa.
Official transcripts from institutions outside the U.S. must be accompanied by an official transcript evaluation from an accredited independent evaluating agency. Please be sure you request a detailed evaluation that includes all course titles, credit hours, grades, U.S. degree equivalency, grade-point averages (GPA), and date of degree conferral. For a list of acceptable foreign credential evaluation services, please visit NACES.
Applicants who are not U.S. citizens are also required to submit official test scores for the Test of English as a Foreign Language (TOEFL) or Pearson’s Test of English (PTE) Academics or the academic International English Language Test System (IELTS). To be considered for admission, there are required scores that you will need to meet. Score requirements may differ by school and program so check the admissions requirements for your program.
Supporting Documents and Official Transcript
Documents and Official Transcripts not submitted online should be mailed to:
Mail: George Washington University
ATTN: Transcript Processing Center
1415 W 22nd St.
Suite 220
Oak Brook, IL 60523
Alternatively, official electronic transcripts can be sent to: transcripts@hsprograms.gwu.edu