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

Those who wish to pursue a managerial career in clinical research while building an advanced understanding of relevant regulations could benefit from The George Washington University's Dual Degree: BSHS in Clinical Research Administration/MSHS in Regulatory Affairs program. Continue reading to learn more about this accelerated online dual degree program.

Official Program Name:

Dual Degree: Bachelor of Science in Health Sciences in Clinical Research Administration / Master of Science in Health Sciences in Regulatory Affairs

School Offering Program:

The George Washington University

Degree Level:

Bachelor's/Master's

Program Prerequisites:

Prospective students of this dual BSHS/MSHS program must have earned an associate's degree or completed 45-60 transferable credits; required coursework includes English composition, physical or natural science with lab, social sciences, and humanities. A 3.3 or above GPA is also required. A fundamental understanding of research processes and strong assessment skills are helpful, as courses are taken in various clinical research concepts and the evaluation of regulatory compliance strategies. All applicants to The George Washington University should have a high school diploma or equivalent; some programs may have additional requirements.

Program Description:

The online Dual Degree: Bachelor of Science in Health Sciences in Clinical Research Administration/Master of Science in Health Sciences in Regulatory Affairs program at The George Washington University combines undergraduate studies in clinical research practices and systems with advanced coursework in regulatory compliance methods. Clinical research topics include processes and documentation in clinical trial monitoring; developmental steps for clinical trials of new medical devices or drug therapies; clinical trial risk assessment strategies, data management, and safety reporting; and clinical trial budgeting. A capstone allows students to more closely examine trial management practices, ethical principles, and technologies. Nine master's-level classes provide study in regulatory strategies regarding development of drugs and devices, the assessment of regulatory compliance issues, change management in regulatory affairs, and international regulatory processes. Elective courses include those in international clinical research, human subject recruitment and interaction, healthcare leadership concepts, and safety assessments in clinical research.

Learning Format:

Online

Program Length:

147 credits.

Financial Aid Available:

Eligible students could be able to receive financial aid in the forms of grants, loans, and scholarships. Contact The George Washington University's financial aid office for more information.

Tuition, Financial Aid & Start Dates

Since every student is different, there isn't a "one size fits all" for school information. Start dates and tuition often vary between selected programs, and financial aid opportunities are unique to each student's circumstances. to get the most up-to-date and accurate information based on your selected program and circumstances.

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Required Courses for a Dual Degree: Bachelor of Science in Health Sciences in Clinical Research Administration / Master of Science in Health Sciences in Regulatory Affairs:

To earn the BSHS, students must complete 120 undergraduate credits; this includes 60 credits taken in the program curriculum and 60 transferable credits to satisfy the general education requirements. An additional 27 credits are taken in graduate-level courses to earn the MSHS. Students with the minimum 45 transferable credits at the bachelor's level must complete 15 credits in general education classes. Degree program and course requirements are subject to change. Contact The George Washington University to confirm the most accurate information before enrolling in a program.

Core Courses (84 credits)

  • Processes of Clinical Research
  • The Business of Clinical Research
  • Epidemiology for Clinical and Translational Research
  • Basics of Clinical Research
  • Good Clinical Practices
  • Capstone in Clinical Research Administration
  • Introduction to Monitoring Clinical Trials
  • Pathophysiology
  • Health Policy and the Health Care System
  • Current Issues in Bioethics
  • Healthcare in Literature
  • Writing in the Health Sciences
  • Informatics in the Health Sciences
  • Introduction to Statistics for Health Sciences
  • Healthcare Law and Regulation
  • Case Studies in Healthcare
  • Introduction to Epidemiology
  • Research and Writing for Health Sciences
  • Topics in Healthcare Leadership
  • Issues and Trends in Health Systems
  • The Healthcare Enterprise
  • Biostatistics for Clinical and Translational Research
  • Introduction to Global Regulatory Affairs
  • Regulatory Strategy in the Development of Drugs and Biologics
  • Regulatory Strategy in the Development of Devices and Diagnostics
  • Integration of Regulatory Science
  • Regulatory Compliance
  • Leadership and Change in Regulatory Affairs

Elective Courses (3 credits)

  • Students choose one of the following courses:
    • Health Economics and Finance
    • Partnerships with Human Subjects
    • International Clinical Research
    • Quality and Risk Management
    • Building a Quality Culture
    • Topics in Health Care Leadership
    • Epidemiology for Clinical and Translational Research

Post-Graduation Opportunities

Furthering Your Education:

Having earned both the BSHS and MSHS degrees, some graduates could choose to continue their studies in a doctoral degree program. A doctorate may be necessary for teaching or administrative positions in colleges or universities or for directorial or senior administrative roles in clinical research organizations. The curriculum for these terminal degrees could address advanced topics in areas of regulations for specific drugs or devices, quality management, data management, or analytical processes.

Doctoral degrees graduates might be prepared to pursue include, but are not limited to:

  • Doctor of Applied Clinical Research
  • PhD in Epidemiology and Clinical Research
  • PhD in Pharmaceutical Sciences - Regulatory Affairs and Quality Assurance

Career Paths:

Graduates of the BSHS in Clinical Research Administration / MSHS in Regulatory Affairs program could be ready to their knowledge of clinical trial procedures and regulatory compliance techniques to management positions in clinical or corporate settings. They might work for government health agencies, pharmaceutical companies, biomedical companies, medical device manufacturers, nonprofit health organizations, or healthcare research centers.

Job titles appropriate for graduates might include:

  • Clinical trial manager
  • Regulatory affairs specialist
  • Regulatory compliance officer
  • Clinical operations research analyst