The George Washington University Online Clinical Research Administration & Regulatory Affairs Programs

The George Washington University (GW) School of Medicine and Health Sciences offers an online master of science in health sciences (MSHS) in clinical research administration, clinical and translational research, and regulatory affairs. In addition, a BSHS in clinical research administration completion degree is offered, as well as two dual degrees: a BSHS/MSHS in clinical research administration and a BSHS in clinical research administration/MSHS in regulatory affairs. Graduate certificates are also offered in each degree. All courses in the graduate certificates may be applied to the respective MSHS degree.

The BSHS in clinical research administration is a degree completion program in which students transfer 45 to 60 credits to the program to earn the degree. Students participate in clinical trials, apply bioethics to research, create clinical development plans, and explore ethical considerations when conducting research.

The MSHS in clinical research administration seeks to prepare students to design, monitor, and manage clinical trials for up and coming medical drugs and therapies. Students also learn to review and analyze research and propose clinical development plans for health care organizations. The program is designed for professionals already working in clinical research or a related field.

The MSHS in clinical and translational research seeks to prepare students to improve patient outcomes and the health of communities through the application of medical research and findings. This research seeks to create medicines, algorithms, devices, and businesses to improve patient health. Graduates learn the skills needed to lead and collaborate with clinicians, other scientists, investigators, and translational research teams, as well as to develop proposals and provide direction in research priorities and best practices.

The MSHS in regulatory affairs seeks to prepare graduates as business leaders equipped with critical thinking skills to make business decisions based on financial principles, the ability to communicate and negotiate professionally, and the ability to apply regulatory affairs strategies to businesses. Students gain a global perspective through an interdisciplinary education based in law, science, and business.

The George Washington University is located just four blocks from the White House in Washington DC. Students attend on campus or online from all 50 states and from countries around the world. Notably, GW’s online programs aim to offer the same opportunities for outstanding education to students not located in the Washington DC area. GW is dedicated to providing an education where students can immediately apply what they learn in the workforce. Their faculty includes experts in health care from corporations, emergency care, and regional health care providers, as well as alumni who are current experts in their fields.

What to Expect from The George Washington University Clinical Research Administration and Regulatory Affairs Programs

Admission Requirements: Applicants to the BSHS in clinical research administration and dual degree programs must hold an associate’s degree or transfer 45 to 60 credits of college coursework to the program. The minimum GPA requirement is 2.5 out of 4.0. Additional materials include an application and application fee, a personal statement, official transcripts, a resume/CV, and one letter of recommendation.

Applicants to the GW MSHS, and graduate certificate programs must hold at least a bachelor’s degree from a regionally accredited institution and have a cumulative GPA of 3.0 or higher. Prospective students must submit an application, application fee, statement of purpose, resume or curriculum vitae, two letters of recommendation, and official transcripts. Applicants must have relevant work experience in clinical research or a related field for the clinical research and health care quality degrees, and relevant work in clinical institutions or healthcare for the regulatory affairs degree. No GMAT/GRE is required.

International students must submit TOEFL or IELTS scores.

Study Plan: The online BSHS and MSHS degrees at GW can be completed in two years; the graduate certificates can be completed in one to two years depending on the certificate; and the dual degree programs can be completed in three years. Programs are designed to be taken one class at a time and courses last seven weeks each. Start dates are offered in the fall, spring, and summer. Each three-credit course is expected to take 18 to 20 hours of work from the student.

Curriculum: The GW BSHS in clinical research administration consists of 60 credits and includes courses such as basics of clinical research, good clinical practices, the business of clinical research, introduction to monitoring clinical trials, pathophysiology, current issues in bioethics, informatics in the health sciences, health care law and regulation, and more. Students also complete a capstone course. Electives include current issues in health science management, disease prevention & health promotion concepts, principles of biostatistics, for health sciences, management of health science services, and quality improvement in health care.

The MSHS degrees consist of 36 credits and the corresponding graduate certificates consist of 18 credits. The breakdown of courses for each degree follows.

MSHS in Clinical Research Administration: 18 credits of core classes, nine credits of strategic leadership courses, six credits of graduate research coursework, and three credits of electives. Courses may include: critical analysis in clinical research, leadership and change in clinical research administration, topics in health care leadership, issues and trends in health systems, biostatistics for clinical and translational research, and more.

Graduate Certificate in Clinical Research Administration: 15 credits from the core courses for the MSHS including these five courses: critical analysis in clinical research, medicines development, partnerships with human subjects, the clinical research industry, and monitoring clinical research. Students take one three-credit elective.

MSHS in Clinical and Translational Research: 27 credits of core classes, nine credits of electives. Courses may include: critical analysis in clinical research, clinical investigation, epidemiology for clinical and translational research, bioinformatics for genomics, and foundations in translational research, among others.

Graduate Certificate in Clinical and Translational Research: 15 credits from the core courses from the MSHS including these courses: critical analysis in clinical research, clinical investigation, foundations in translational research, grantsmanship in translational research, transdisciplinary research proposal, and collaboration and team science in practice and research. Students take one three-credit elective.

Graduate Certificate in Clinical Research Practice: 15 credits from the core courses from the MSHS in clinical and translational research including these courses: critical analysis clinical research, clinical investigation, biostatistics translational research, epidemiology translational research, and bioinformatics for genomics. Students also take one three-credit elective.

MSHS in Regulatory Affairs: 18 credits of core classes, six credits of research courses, nine credits of professional courses, and three credits of electives. Courses may include: introduction to global and regulatory affairs, regulatory strategy in the development of drugs and biologics, leadership and change in regulatory affairs, and topics in healthcare leadership, among others.

Graduate Certificate in Regulatory Affairs: 18 credits from the courses from the MSHS, including these courses: introduction to global and regulatory affairs, regulatory strategy in the development of drugs and biologics, clinical research for regulatory affairs, regulatory compliance, and biostatistics for clinical and translational research.

The dual BSHS/MSHS in clinical research administration comprises 120 credits, which includes nine undergraduate credits that can be applied to the MSHS degree and 27 more graduate credits. The degrees are conferred sequentially as students meet the course requirements. Courses may include the business of clinical research, monitoring clinical trials, medicines development, the clinical research industry, quality and risk management, leadership and change in clinical research administration, principles of biostatistics for health sciences, the health care enterprise, and more. Electives include international clinical research and monitoring, auditing, and oversight in clinical research. Students also complete a capstone in clinical research administration.

The dual BSHS in clinical research administration/MSHS in regulatory affairs comprises 120 credits, which includes nine undergraduate credits that can be applied to the MSHS degree and 27 more graduate credits. The degrees are conferred sequentially as students meet the course requirements. Courses may include processes of clinical research, writing in the health sciences, biostatistics for clinical and translational research, introduction to global regulatory affairs, regulatory compliance, and leadership and change in regulatory affairs. There are several electives to choose from which may include health economics and finance, partnerships with human subjects, building a quality culture, topics in health care leadership, and epidemiology for clinical and translational research.

Online Experience: Students in GW’s online BSHS, MSHS and graduate certificate programs begin with a virtual new student orientation. Each student is also assigned an academic advisor. GW uses Blackboard for online learning experiences, syllabi, assignments, communications, forums, discussion groups, tests, and quizzes. The university provides 24/7 online technical support should students have problems or need assistance.

On-Site Requirements: There are no on-site requirements for the online BSHS degree, dual degrees, MSHS degrees and graduate certificates from George Washington University as the programs are 100 percent online. Students are invited to participate in graduation on campus.

Paying for the George Washington University Clinical Research Administration and Regulatory Affairs Programs

George Washington University charges $615 per credit for the BSHS in clinical research administration. The dual degrees are billed at $615 per credit for the undergraduate portion and $980 per credit for the graduate portion. GW charges $1,315 per credit for the online MSHS in clinical and translational research and corresponding graduate certificates. The other MSHS programs and graduate certificates cost $980 per credit. Since tuition changes from year to year, online students should contact the admissions department of the MSHS and graduate certificate programs for exact costs.

As a final note, GW offers financial aid in the form of scholarships, grants, and student loans. Local students can also apply for work/study opportunities, and applicants may procure outside resources for help paying for their advanced degree. Some companies even offer tuition reimbursement programs for employees seeking an advanced degree.

The George Washington University School of Medicine & Health Sciences MSHS in Health Care Quality

  • Courses include Topics in Healthcare Leadership, Healthcare Quality Landscape, Patient Safety Systems, and more
  • Focus on quality patient care and patient safety
  • Conduct research and learn to implement data analysis tools for effective change
Program Essentials
Degree Level Master's Degree
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 36
Time to Complete? Can be completed in 2 years
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in clinical research or a related field
Program Tuition
Credit Hours 36
Cost Per Credit Hour $980
Total Program Tuition * $35,280.00

The George Washington University School of Medicine & Health Sciences MSHS in Clinical Research Administration

  • Focus on ethics, regulations, and processes for product development
  • Courses include Medicines Development, Quality and Risk Management, The Clinical Research Industry, and more
  • Extremely flexible online courses with each "session" lasting about 1 week
Program Essentials
Degree Level Master's Degree
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 36
Time to Complete? Can be completed in 2 years
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in clinical research or a related field
Program Tuition
Credit Hours 36
Cost Per Credit Hour $980
Total Program Tuition * $35,280.00

The George Washington University School of Medicine & Health Sciences MSHS in Regulatory Affairs

  • Prepare to manage the most iportant elements of the clinical research regulatory process
  • Focus on global health and cost control outcomes
  • Courses include Clinical Research for Regulatory Affairs, Issues and Trends in Health Systems, and Regulatory Strategies
Program Essentials
Degree Level Master's Degree
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 36
Time to Complete? Can be completed in 2 years
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in healthcare or clinical institutions
Program Tuition
Credit Hours 36
Cost Per Credit Hour $980
Total Program Tuition * $35,280.00

The George Washington University School of Medicine & Health Sciences Graduate Certificate in Health Care Quality

  • Apply your certificate to the MSHS in Health Care Quality
  • Prepare to fill the need for patient quality and safety specialists
  • Designed for busy professionals who work full-time
Program Essentials
Degree Level Post-Bachelor's Certificate
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 18
Time to Complete? Can be completed in 2 years.
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in clinical research or a related field
Program Tuition
Credit Hours 18
Cost Per Credit Hour $980
Total Program Tuition * $17,640.00

The George Washington University School of Medicine & Health Sciences Graduate Certificate in Clinical Research Administration

  • Apply your certificate to the MSHS in Clinical Research Administration
  • Courses include Clinical Analysis in Clinical Research, Partnerships with Human Subjects, and Quality and Risk Management
  • Focus on business and scientific processes for product development
Program Essentials
Degree Level Post-Bachelor's Certificate
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 18
Time to Complete? Can be completed in 2 years.
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in clinical research or a related field
Program Tuition
Credit Hours 18
Cost Per Credit Hour $980
Total Program Tuition * $17,640.00

The George Washington University School of Medicine & Health Sciences Graduate Certificate in Regulatory Affairs

  • Apply your certificate to the MSHS in Regulatory Affairs
  • Focus on ensuring new medical product safety, quality, and efficacy
  • Developed through collaborations with the FDA and regulatory affairs professionals
Program Essentials
Degree Level Post-Bachelor's Certificate
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 18
Time to Complete? Can be completed in 2 years.
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? No
Work Experience Required? Yes, Relevant work experience in healthcare or clinical institutions
Program Tuition
Credit Hours 18
Cost Per Credit Hour $980
Total Program Tuition * $17,640.00

The George Washington University School of Medicine & Health Sciences Graduate Certificate in Clinical and Translational Research

  • Apply your certificate to the online MSHS in Clinical and Translational Research
  • The certificate capitalizes on the prerequisite courses of the MSHS in CTR degree to prepare the graduate with the requisite skills to conduct clinical research in collaboration with sponsored research programs
  • Focus on collaborating with, researching with, and leading other professionals, scientists, and research teams
Program Essentials
Degree Level Post-Bachelor's Certificate
Program Start Dates Spring, Summer, Fall
Credits Needed to Graduate 21
Time to Complete? Can be completed in 2 years.
100% Online? Yes
Program Accreditation None
Areas of Concentration None
Program Admissions
Level of Education Required? Bachelor's Degree or Master's Degree
GRE or GMAT Required? Yes
Work Experience Required? Yes, Relevant work experience in clinical research or a related field
Program Tuition
Credit Hours 21
Cost Per Credit Hour $1,315
Total Program Tuition * $27,615.00

* Tuition is calculated based on credits, at the currently published tuition rate. For programs with variable tuition rates, we use the out of state, part-time student rate. Tuition number represents the cost of tuition for the entire program, not per semester or year. Total cost of tuition does not include additional fees.