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Dual Degree: BSHS in Clinical Research Administration / MSHS in Regulatory Affairs

Dual Degree: BSHS in Clinical Research Administration to MSHS in Regulatory Affairs Program Overview

Our multi-level, dual-degree learning option provides you with 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.

Quick Facts

87

total credits

100% online

4-5 years

average duration

Accreditation and Rankings

  • Fully accredited by the Middle States Association of Colleges and Schools
  • Institutional Member of the Consortium of Academic Programs in Clinical Research (CoAPCR)  
  • #66 Best National University*
  • #19 Best Online Bachelor’s Programs*

* U.S. News & World Report‘s 2021 Best Colleges Rankings

Program Highlights

  • 100% online, no campus visits are required
  • Both degrees are conferred sequentially
  • Transfer up to 60 total credits from a regionally accredited institution into the undergraduate portion of the program
  • Nine credits of the MSHS in Regulatory Affairs are completed in the undergraduate portion of the program and charged at the undergraduate per-credit cost

Curriculum

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 (of which 60 credits must be taken at GW; nine of those credits will be graduate level courses that will be taken during the BSHS portion 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.

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Curriculum: 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 practices, clinical trial research, health equity, bioethics, quality assurance and control, and global regulatory strategy. 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 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 (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 a Dual Degree?

By completing nine credits of graduate coursework as part of the BSHS in Clinical Research By completing nine credits of graduate coursework as part of the BSHS in Clinical Research Administration, you can then 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 that are part of the program 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 Regulatory Affairs:

  • Provide strategic direction and integrate business needs in matters of regulatory science and affairs in the health care industry.
  • Lead and collaborate with the private sector and governmental stakeholders for effective development of 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 trial and public health data to develop successful regulatory strategies.
  • Navigate the submission and review process domestically and internationally.
  • Manage regulatory aspects 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 interested in how new medical products intersect with regulatory and ethical frameworks, this degree program could be for you. From the foundations provided in the clinical research administration BSHS, to the finer points of 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.

Career Outlook

With the skills gained in our 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, $67,360 median salary1
  • Regulatory Compliance Officer, $60,522 median salary2
  • Clinical Research Coordinator, $49,057 median salary3
  • Clinical Research Associate, $63,845 median salary4

Admission Requirements

To apply for the Dual Degree BSHS in Clinical Research Administration/MSHS in Regulatory Affairs, you’ll need:

  • Completed application and $80 application fee
  • At least 45 credit hours of college-level coursework or an associate degree.
  • 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

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.

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Tuition Details

The Dual Degree BSHS in Clinical Research Administration/MSHS in Regulatory Affairs at GW consists of 87 credit hours. Please find the cost per credit hour and total estimated program costs here.

Tuition for the BSHS undergraduate courses is $615 per credit hour. MSHS graduate course tuition is $980 per credit hour.

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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.

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 (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.

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.

Frequently Asked Questions

As you explore an online program at the George Washington University, our dedicated staff is here to support you. If you have a question we don’t cover here, request more information or call 844-386-7323.

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Sources:

  1. Payscale.com (28 February 2020) Regulatory Affairs Specialist Salary. Retrieved March 17, 2020, from https://www.payscale.com/research/US/Job=Regulatory_Affairs_Specialist/Salary/
  2. 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/
  3. Payscale.com (2019, September 10). Clinical Research Coordinator. Retrieved March 9, 2020, from https://www.payscale.com/research/US/Job=Clinical_Research_Coordinator/Salary/
  4. Payscale.com (2019, September 10). Clinical Research Associate. Retrieved March 9, 2020, from https://www.payscale.com/research/US/Job=Clinical_Research_Associate_(CRA)/Salary/