Online Dual Degree: BSHS in Clinical Research Administration and MSHS in Regulatory Affairs Program Overview
Our multi-level, online dual degree provides a seamless way to earn your BSHS in Clinical Research Administration and an MSHS in Regulatory Affairs through an accelerated format, allowing you to earn your BSHS and MSHS in less time by combining the work toward both degrees.
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Note, 45 transferrable credits required to apply for BSHS and BSHS/MSHS dual degree programs.
Accreditation and Rankings
- Fully accredited by the Middle States Association of Colleges and Schools
- #63 Best National University*
- #14 Best Online Bachelor’s Programs*
- #8 Best Online Bachelor’s Programs for Veterans*
* The U.S. News & World Report – 2022 Rankings
- 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 Regulatory Affairs are completed during the BSHS portion of the program and billed at the undergraduate rate
This multi-level online dual degree program offers academically qualified individuals a seamless and accelerated pathway for completing both the Bachelor of Science in Health Sciences (BSHS) in Clinical Research Administration and the Master of Science in Health Sciences (MSHS) in Regulatory Affairs. Undergraduate and graduate degrees will be conferred sequentially, with the BSHS awarded upon completion of 120 credits. Students must take 60 credits at GW, including 9 credits of graduate-level courses taken during the BSHS and billed at the undergraduate tuition rate. The MSHS is awarded following completion of an additional 27 credits (9 courses) of graduate coursework that includes one elective course.View Courses
Learn to Ensure Quality and Compliant Clinical Research Conduct and Gain an Understanding of Global Regulatory Strategy
In coursework for the dual BSHS in Clinical Research Administration / MSHS in Regulatory Affairs, you’ll study processes of clinical research, good clinical pIn coursework for this online dual degree, you’ll study processes of clinical trial research, good clinical practices, health equity, bioethics, quality assurance and control, and global clinical regulatory affairs and strategy. This online dual degree program is rigorous and designed for motivated, high-performing students. This program is ideal for students that would like to make a difference in supporting clinical trials and global regulatory strategy for investigational products.
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:
- 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 CCRP® certification through the Society of Clinical Research Associates.
Why Choose an Online Dual Degree?
By completing nine credits of graduate coursework as part of the BSHS in Clinical Research Administration, you can complete your MSHS in Clinical Regulatory Affairs in around four semesters rather than six semesters.
You’ll also save money because the nine credit hours of graduate coursework part of the program will be charged at the undergraduate tuition rate instead of the graduate tuition rate.
Program outcomes for the BSHS in Clinical Research Administration:
- Integrate scientific, medical, regulatory, and commercial requirements to create clinical development plan sections that provide for benefit and risk assessments to develop 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 clinical trials, 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 through clinical trials
Program outcomes for the MSHS in Regulatory Affairs:
- Provide strategic direction and integrate business needs in matters of clinical regulatory affairs
- Lead and collaborate with the private sector and government stakeholders to effectively develop medical products
- Understand the philosophies and roles of the domestic and international regulatory agencies that oversee drugs, biologics, medical devices, and diagnostics
- Evaluate the scientific and economic value of bringing new health care products into the global market
- Analyze clinical trials and public health data to develop regulatory strategies
- Navigate the submission and review process domestically and internationally
- Manage clinical regulatory affairs throughout the product life cycle
- Understand the factors that influence health care policy on a national and local level and how policies influence regulatory practice
Who Is the Ideal Student for This Program?
If you are driven to be a leader in the rapidly growing clinical research field and are interested in how new medical products intersect with clinical regulatory affairs and ethical frameworks, this online dual degree program could be for you. From the foundations provided in the clinical research administration BSHS to the finer points of clinical regulatory affairs in the MSHS program, this online program is designed to prepare you for the challenges of today’s health care innovation sector. To succeed, you should be self-disciplined, self-directed, and ready to collaborate with faculty and classmates online.
With the skills gained in our online dual degree program in clinical research administration and regulatory affairs, you will be ready to enter a variety of jobs throughout the medical innovation field:
- Regulatory affairs specialist, $70,330 median salary1
- Regulatory compliance officer, $60,522 median salary2
- Clinical research coordinator, $49,901 median salary3
- Clinical research associate, $68,205 median salary4
To apply for the online dual degree in BSHS in Clinical Research Administration and MSHS in Regulatory Affairs, you’ll need:
- Completed application and $80 application fee
- 3.3 GPA or above on a 4.0 scale
- 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
- 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)
- 3 to 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 or 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.See All Requirements
Meet the Program Directors
GW’s experienced faculty provides you with the rich, practical knowledge and support needed to succeed in the program and your career.
Kathleen Thoma, EdD, CCRP, CPH
Assistant Professor of Clinical Research and Leadership
Dr. Thoma is a full-time faculty member 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, where she managed many NIH and industry-sponsored clinical trials during her tenure. Her expertise involved working with NIH-sponsored trials through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network and the Pediatric HIV/AIDS Cohort Study network.
She has also held positions as research project manager for the Pediatric Research in Office Settings 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 CCRP through the Society of Clinical Research Associates and holds the Certified in Public Health (CPH) credential from the National Board of Public Health Examiners.
In addition to clinical research, her interests include HIV/AIDS, health literacy, health disparities, the psycho-social determinants of health and health behavior, and patient-centered outcomes research.
Melissa Tice, PhD
Assistant Professor of Clinical Research and Leadership
Dr. Tice has been in the field of regulatory affairs for over 23 years out of a total of 30 years of experience in the pharmaceutical/biotech industry. Her expertise in regulatory affairs ranges from developing regulatory strategies for drug development programs and obtaining global health authority approvals for key therapeutics in the fields of oncology, cardiovascular disease and vaccines.
- Payscale.com (25 January 2022) Regulatory Affairs Specialist Salary. Retrieved February 14, 2022, from https://www.payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary/.
- Payscale.com (14 September 2019) Regulatory Compliance Officer Salary. Retrieved January 7, 2020, from https://www.payscale.com/research/US/Job=Regulatory_Compliance_Officer/Salary/.
- Payscale.com (2022, January 28). Clinical Research Coordinator. Retrieved February 14, 2022, from https://www.payscale.com/research/US/Job=Clinical_Research_Coordinator/Salary/.
- Payscale.com (2022, January 31). Clinical Research Associate. Retrieved February 14, 2022, from https://www.payscale.com/research/US/Job=Clinical_Research_Associate_(CRA)/Salary/.