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

JUMP TO :

• BSHS - Clinical Research Administration
• BSHS - Clinical Research Administration/MSHS - Regulatory Affairs
• BSHS/MSHS - Clinical Research Administration
• Graduate Certificate - Clinical and Translational Research
• Graduate Certificate - Clinical Research Administration
• Graduate Certificate - Clinical Research Practice
• Graduate Certificate - Regulatory Affairs
• MSHS - Clinical & Translational Research
• MSHS - Clinical Research Administration
• MSHS - Regulatory Affairs

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. Finally, a doctorate of health sciences (DHSc) leadership in clinical practice and education is offered with two tracks: clinical practice leadership and educational practice leadership.

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 DHSc leadership in clinical practice and education program prepares students to design, evaluate, and implement programs to advance health care. Two separate weekend campus residencies and a finalized manuscript for submission to a peer-review journal are part of the program requirements.

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.

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.

Applicants to the online DHSc must have a master’s degree from an accredited institution, as well as an entry-level degree such as an MD, DPT, PA, OTD, MSN, or DNP in biomedical science or some other health-related field. Application materials include the application and fee, a 250-500 word personal statement, a resume or CV, two letters of recommendation, official transcripts from all institutions/programs attended, and proof of at least one year of healthcare-related clinical practice or health administration or leadership experience.

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. The DHSc can be completed in 2.5 years or 30 months. 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. In addition to the immersion weekends for the DHSc leadership program, students prepare a finalized manuscript for submission to a peer-review journal.

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 12 to 21 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: 21 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: 12 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 a total of 147 credits, which includes nine undergraduate credits that can be applied to the MSHS degree and 27 more graduate credits. Because 60 credits can be transferred in, this degree requires 87 credits to be completed through GW. 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 a total of 147 credits, which includes nine undergraduate credits that can be applied to the MSHS degree and 27 more graduate credits. Because 60 credits can be transferred in, this degree requires 87 credits to be completed through GW. 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.

The DHSc leadership in clinical practice and education program comprises 48 credits and includes two tracks: clinical practice leadership and education practice leadership. Core courses for both tracks include interprofessional collaboration in practice, HP practicum I-II, program theory and innovation in the health professions, academic and clinical leadership in the HP, bioethical implications of health research, advanced statistical methods for clinical and translational research, research methods in HP I-II, and seminar I-III. Optional electives for both tracks include finance for health care operations, measurement of human function and learning, qualitative methods for HP leadership, mixed methods in translational health sciences, independent study for health professionals, and the health care enterprise.

Clinical practice leadership courses include health information, quality, and outcomes, introduction to health care quality, knowledge translation health care, and health care research.

Education practice leadership courses include teaching strategies in the health professions, curriculum development in the health professions, assessment in HP education, and technology and education in HP.

Online Experience: Students in GW’s online BSHS, MSHS, and graduate certificate programs begin with 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 from the DHSc leadership program come to campus for two weekend immersions. Online students are also invited to participate in graduation on campus.

George Washington University charges $635 per credit for the BSHS in clinical research administration. The dual degrees are billed at $745 per credit plus fees. 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 $990 per credit plus fees. The DHSc program also costs $990 per credit plus fees. 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 degrees. Some companies even offer tuition reimbursement programs for employees seeking an advanced degree.