Accelerate your career with The George Washington University’s (GW) Dual Degree: BSHS in Clinical Research Administration/MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program. Combine the work of earning your BSHS and MSHS and save time on your path to a career in health care.
With the skills you’ll gain in this online dual degree program, you’ll be ready to support clinical research that protects patients through addressing ethical, business and legal considerations and developing regulatory strategies to ensure successful medical product development and approval.
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QUICK FACTS:
87
Total Credits
100%
Online
48-60 months
Average Duration
Accreditation and Rankings
- GWU is accredited by the Middle States Commission on Higher Education
- #62 Best National University*
- #15 Best Online Bachelor’s Programs*
- #8 Best Online Bachelor’s Programs for Veterans*
* The U.S. News & World Report – 2023 Rankings
Program Highlights
- 100% online dual degree, no campus visits are required
- Both degrees are conferred sequentially
- Transfer in 45-60 total credits from a regionally accredited institution to the undergraduate portion of the program
- Nine credits of the MSHS in the Leadership and Strategy in Regulatory Affairs and Clinical Research Administration Program are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost
- During the MSHS degree portion, specialize your degree by choosing from two concentrations: Regulatory Affairs or Clinical Research Administration
Curriculum: Learn to Ensure Quality and Compliant Clinical Research Conduct, Create Effective Regulatory Strategies and Apply Leadership Skills
In coursework for the dual BSHS in Clinical Research Administration / MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration you’ll study processes of clinical research, good clinical practices, health equity, bioethics, quality risk management, regulatory strategy, medical product development and registration, and leadership. Due to its rigor, this dual degree program is designed for motivated, high-performing students. This program is ideal for students that would like to take a leadership role in clinical research administration.
By completing the BSHS in Clinical Research Administration, you’ll satisfy 1,500 hours of professional experience towards the 3,000 professional experience hour requirement for the following certifications through the Association of Clinical Research Professionals (ACRP):
- CCRA® (Certified Clinical Research Associate)
- CCRC® (Certified Clinical Research Coordinator)
- CPI® (Certified Principal Investigator)
- ACRP-CP® (ACRP Certified Professional)
You will also satisfy one year of the two-year full-time work experience requirement for the Certified Clinical Research Professional (CCRP®) certification through the Society of Clinical Research Associates (SOCRA).
Why Choose an Online Dual Degree?
By completing nine credits of graduate coursework as part of the BSHS in Clinical Research Administration, you will then be able to complete your MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration in around four and a half semesters rather than six.
You’ll also save money because students will take nine credit hours of graduate coursework during the undergraduate part of the program that will be charged at the undergraduate tuition rate instead of the graduate tuition rate.
Program Outcomes
Program outcomes for the BSHS in Clinical Research Administration:
- Integrate scientific, medical, regulatory, and commercial requirements to create clinical development plan (CDP) sections that provide for benefit and risk assessments in the development of a new investigational product.
- Analyze strategies to address ethical and cultural considerations for effective and compliant clinical trial conduct in national and international settings.
- Compare clinical, regulatory, and business requirements in the planning and conduct of a clinical trial, including data integrity and documentation.
- Communicate effectively with diverse stakeholders, individually and in group settings, using verbal, written, and electronic modes of communication.
- Explain structural determinants adversely impacting the health of socially disadvantaged groups from diverse perspectives.
Program outcomes for the MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration:
- Regulations and fundamentals of clinical development: Create clinical and regulatory plans for the development of investigational therapeutics that adhere to domestic and international laws, regulations, and pre- and post-approval requirements.
- Leadership and strategy: Lead interdisciplinary team to develop strategies to ensure successful pharmaceutical/medical device product development, regulatory approvals, and marketing activities.
- Quality and compliance: Formulate 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: Strategize 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?
This program is designed for anyone interested in joining the thriving clinical research and regulatory affairs industry. If you’re interested in helping advance the regulatory strategy, development, investigation and approval of new medications, products, and therapeutic treatments, this program could be for you. To succeed, you should be self-disciplined, self-directed, and ready to collaborate with faculty and diverse, fellow learners in online formats.
Career Outlook
With the skills gained in our online health sciences dual degree program in clinical research administration and regulatory affairs, you will be ready to enter a variety of jobs throughout the clinical research administration and regulatory affairs fields:
- Regulatory affairs specialist, $73,090 avg. salary1
- Regulatory compliance officer, $60,522 avg. salary2
- Clinical research coordinator, $52,319 avg. salary3
- Clinical research associate, $73,307 avg. salary4
Admission Requirements
To apply for the online dual degree in BSHS in Clinical Research Administration and MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration, you’ll need:
- Completed application and $80 application fee
- 3.3 GPA or above on a 4.0 scale
- Resume/CV
- Personal statement of 250-500 words that includes reasons for pursuing this degree, any qualifications, accomplishments or honors, and career goals
- Two letters of recommendation from a previous instructor or employer
- 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.
- Prerequisite Coursework: Applicants must have completed 45-60 credits of college-level coursework at a regionally accredited institution of higher education. These completed courses should contain the following General Education courses (students who are missing one or two of these courses may be admitted but must complete them at another college or university and transfer them in to GW before they will be able to graduate from GW).
- 6 credits in English composition
- 3 credits in college mathematics (college algebra, statistics, or above)
- 4 credits in natural or physical science with a lab
- 6 credits in social sciences
- 3 credits in humanities
If you have an associate degree from a participating D.C., Maryland, Virginia community college, you may be eligible for guaranteed admission to this program. Review the list of participating institutions or complete this form to speak with an Online Admissions Advisor for more details.
Tuition Details
The online BSHS in Clinical Research Administration/MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration dual degree at GW consists of 87 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 Directors
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.
Robin McGarry, MD
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Dr. McGarry is the Program Director of the MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration Program. She has taught Clinical Research for Regulatory Affairs in the CRL Regulatory Affairs Program for 3 years. Dr. McGarry is a board-certified internist and nephrologist with over 30 years of experience in the pharmaceutical industry, including over 15 years as a clinical regulatory consultant. She has held positions in both large and small pharmaceutical companies including Immunomedics, Inc., Astellas Pharma, Inc., Pfizer, Inc., Zambon Corp., Ciba-Geigy Corp. (now Novartis), and ICI Pharmaceuticals (now Astra-Zeneca). These positions included senior leadership/functional and line management of global pharmacovigilance organizations, medical affairs and clinical development groups, and matrix management of multidisciplinary groups for product development teams and various special projects. Throughout her career, she has collaborated closely with regulatory affairs groups, contributing to regulatory strategic approaches, based on her experience across various pharmaceutical functions and in-depth knowledge of global health authority regulations and requirements. ;Her teaching experience in the pharmaceutical industry includes developing and conducting workshops and lectures for various clinical development, medical, pharmacovigilance, and regulatory topics. Dr. McGarry holds a B.S. degree in Biology from Georgetown University and an M.D. from UMDNJ-New Jersey Medical School (now Rutgers New Jersey Medical School, Newark, NJ). She completed her internal medicine residency at UMDNJ-University Hospital and Affiliated Hospitals, including Chief Resident in Internal Medicine at the East Orange, NJ Veterans Administration Medical Center and a clinical nephrology fellowship at New England Medical Center, Tufts University School of Medicine, Boston MA.
Kathleen Thoma, EdD, CCRP, CPH
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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 and Disclaimer:
- Payscale.com (2023). Regulatory Affairs Specialist Salary. Retrieved October 10, 2023
- Payscale.com (2023). Regulatory Compliance Officer Salary. Retrieved October 10, 2023
- Payscale.com (2023). Clinical Research Coordinator Salary. Retrieved October 10, 2023
- Payscale.com (2023). Clinical Research Associate Salary. Retrieved October 10, 2023
*The total number of credits and program duration depend on the number of transferred credits.