Explore core competencies across two exciting concentrations
100% Online
24 Months*
Leadership and Strategy in Regulatory Affairs and Clinical Research Administration will change its name to Regulatory Affairs and Clinical Research Leadership, starting in Fall 2024.
Offered through The George Washington University (GW) School of Medicine and Health Sciences (SMHS), the online Master of Science in Health Sciences (MSHS) in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program is designed to give you practical knowledge about the key elements of clinical research administration and regulatory affairs from a global perspective.
This program incorporates global regulatory strategy and clinical research industry-specific concepts across the curriculum to equip you with the critical thinking skills you need to succeed in these fields.
*The total number of credits and duration of the program depend on the number of transferred credits
To learn more about our programs, you can register for our upcoming events.
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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 on-campus residency required
- Complete your degree in 24 months part-time
- 2 concentration options: regulatory affairs and clinical research administration
- Developed in collaboration with regulatory affairs and clinical research professionals working in the industry and governmental agencies including the FDA and NIH
- Strong national alumni network
Who Is the Ideal Student for This Program?
The online MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program is ideal for regulatory affairs, clinical research and health care professionals looking to lead regulatory strategy and therapeutic product development in the evolving field of health care.
Program Outcomes
As a graduate of this program, you will be fully prepared to:
- 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
- Lead interdisciplinary team to develop strategies to ensure successful pharmaceutical/medical device product development, regulatory approvals, and marketing activities
- 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
- Strategize the therapeutic product lifecycle to address the evolving global legal, clinical, and regulatory requirements in the healthcare industry
Career Outlook
The online MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program takes a real-world approach to create effective leaders and communicators across a range of positions.
According to the U.S. Department of Labor and the National Center for O*NET Development, the median wage for Regulatory Affairs Managers is $128,620 annual, with 94,400 projected job openings by 2032.1 In addition, clinical research director positions have an average annual salary of $121,579.2
Meet the growing demand for qualified professionals while you prepare to fill a variety of roles, including:
- Regulatory Affairs Specialist: $73,090 avg. salary3
- Regulatory Affairs Manager: $110,916 avg. salary4
- Senior Chemistry, Manufacturing, and Controls (CMC) Manager: $115,000 avg. salary5
- Clinical Research Coordinator, $52,319 avg. salary6
- Clinical Research Associate, $73,307 avg. salary7
- Clinical Data Manager, $78,920 avg. salary8
Admission Requirements
To be accepted into this program, you must have:
- Completed application
- 3.0 GPA or above on a 4.0 scale
- A bachelor’s degree from a regionally accredited institution
- Official transcripts from every college and university attended*
- Resume/CV
- Personal statement
- Two letters of recommendation from a current/former employer or instructor
- Previous work experience: health care related experience preferred
*All non-U.S. transcripts (including those in English) must be evaluated by an accredited foreign credential agency.
Tuition Details
The MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program at GW consists of 36 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 J. McGarry, M.D.
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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.
Kathy 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
- 11-9199.01 – Regulatory Affairs Managers. (2023). Retrieved October 24, 2023, from Onetonline.org
- Payscale.com (2023 October 11). Clinical Research Director. Retrieved October 24 2023, from Payscale - Clinical Research Director Salary
- Payscale (2023 October 8). Regulatory Affairs Specialist. Retrieved October 24, 2023, from Payscale - Regulatory Affairs Specialist Salary
- Payscale (2023 October 4). Regulatory Affairs Manager. Retrieved October 24, 2023, from Payscale - Regulatory Affairs Manager Salary
- Payscale (2023 January 8) Senior Chemistry and Manufacturing Controls (CMC) Project Manager. Retrieved October 24, 2023, from Payscale - Senior CMC Project Manager Salary
- Payscale.com (2023, October 10). Clinical Research Coordinator. Retrieved October 24, 2023, from Payscale - Clinical Research Coordinator Salary
- Payscale.com (2023, October 9). Clinical Research Associate. Retrieved October 24, 2023, from Payscale - Clinical Research Associate Salary
- Payscale.com (2023, October 10). Clinical Data Manager. Retrieved October 24, 2023, from Payscale - Clinical Data Manager Salary
Curriculum Details
36 TOTAL CREDITS REQUIRED
The online MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program consists of seven core courses, four concentration course, and one elective course for a total of 36 credits.
This program is 100% online, features no on-campus residencies, and you can graduate in just 24 months part-time.
Core Courses
- RCR 6201 Introduction to Global Regulatory Affairs and Clinical Research
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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 6202 Regulatory Strategy in the Development of Therapeutics
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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.
- RCR 6206 International Regulatory Affairs and Clinical Research
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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.
- HSCI 6264 Epidemiology
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Students explore the basic concepts of epidemiology which includes various epidemiological study designs used to examine disease frequency, cause-effect relationships between risk factors and disease states, and effects of bias as examples. Students apply epidemiologic concepts in the context of translational research.
- COHM 6235 Leadership Development in Healthcare Systems
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Overview of principles related to leadership, including theories and styles, organizational management and values, communication strategies, and change in the context of healthcare systems.
- COHM 6245 Strategic and Operational Decision Making for Health Care Leaders
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Overview of business principles related to health care systems and leadership, focusing on strategic management of health care service delivery in various settings. Credit cannot be earned for this course and HSCI 6241.
Core Courses – Choose one of the following based on concentration
- RAFF 6275 Leadership in Regulatory Affairs
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Theories of leadership and change are integrated in the development of change proposals for the regulatory affairs field. The development of leadership solutions to problems in leading regulatory strategic change; integration of all field coursework into implementation plans for health care system changes.
- CRA 6275 Leadership and Change in Clinical Research Administration
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A capstone course focusing on the concept of leadership within the contexts of health professionals, health systems, and health policy.
RAFF Concentration Courses
- RAFF 6203 Regulatory Strategy in the Development of Devices and Diagnostics
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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
- RAFF 6204 Clinical Research for Regulatory Affairs
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The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals. Prerequisite: RCR 6201.
- RAFF 6205 Regulatory Compliance
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Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use. Prerequisites: RCR 6201
- RAFF 6207 Promotion of FDA-Regulated Medical Products
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Exploration of FDA-regulated advertising and promotion of pharmaceutical drugs. Focus on pre- and post-market issues for prescription drugs and management of risks and compliance surrounding medical and commercial communications. Prerequisites: RCR 6201 and RCR 6202.
CRA Concentration Courses
- CRA 6203 Partnerships with Human Subjects
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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 6204 The Clinical Research Industry
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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.
- CRA 6209 Quality and Risk Management
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This course explores how to manage risk and safety assessments to ensure quality in clinical research.
- CRA 6211 Monitoring, Auditing and Oversight in Clinical Research
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Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.
RAFF Concentration Electives (Take One)
- HSCI 6263 Biostatistics for Clinical and Translational Research
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Basic concepts and methods of biostatistics applied to translational research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi.
- CRA 6203 Partnerships with Human Subjects
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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
-
This course explores how to manage risk and safety assessments to ensure quality in clinical research.
- CRA 6211 Monitoring, Auditing and Oversight in Clinical Research
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Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.
CRA Concentration Electives (Take One)
- HCQ 6201 Building a Quality Culture
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Application of leadership and organizational change theories and principles to the implementation of quality and patient safety initiatives. Focus on strategies for developing the culture and infrastructure needed to support patient safety and continuous quality improvement.
- HSCI 6263 Biostatistics for Clinical and Translational Research
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Basic concepts and methods of biostatistics applied to translational research. Topics include distributions, populations and sample selection, variables, interaction and confounding, hypothesis formulation, correlation, t-tests, ANOVA, regression, and chi.
- RAFF 6204 Clinical Research for Regulatory Affairs
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The planning and conduct of clinical trials. Topics include protocol development, study design, post-marketing surveillance, and evaluation and assessment of regulatory submissions. Strategies for achieving clinical development goals. Prerequisite: RCR 6201.
- RAFF 6205 Regulatory Compliance
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Analysis and evaluation of regulatory affairs compliance strategies and guidelines. Pre and post marketing compliance of medical products, oversight, labeling, advertising and use. Prerequisites: RCR 6201
- RAFF 6207 Promotion of FDA-Regulated Medical Products
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Exploration of FDA-regulated advertising and promotion of pharmaceutical drugs. Focus on pre- and post-market issues for prescription drugs and management of risks and compliance surrounding medical and commercial communications. Prerequisites: RCR 6201 and RCR 6202.
NOTE: All classes are three credits each.
Key Dates
|
Summer 2024 |
Fall 2024 |
Spring 2025 |
|
| Application Deadline |
March 20, 2024 (Closed) |
July 20, 2024 (Open) |
December 1, 2024 (Open) |
Admissions Requirements
To be accepted to the MSHS in Leadership and Strategy in Regulatory Affairs and Clinical Research Administration program (100% online), you must have:
- Completed application
- 3.0 GPA or above on a 4.0 scale
- A bachelor’s degree from a regionally accredited institution
- 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 from a current/former employer or instructor
- 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: health care related experience preferred
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