Online Clinical Research and Regulatory Affairs Programs

Program Highlights:

• Graduate in as few as 28 months
• Two concentration options to choose from
• Design programs to advance the practice of health professionals in academic and clinical settings
• There are two residencies required over separate weekends, and the program culminates with a finalized manuscript ready for submission to a peer review journal.

Gain a mastery of the design, implementation and evaluation of health care programs, lead interprofessional teams, and evaluate evidence to advance health care. The program prepares those in clinical health positions from a range of backgrounds who seek to build competencies in advanced professional practice, whether that be in the clinical or academic environments.

The curriculum is primarily online, meaning you continue in your profession full-time, learning when and where it is most convenient to you. There are two residencies required over separate weekends, and the program culminates with a finalized manuscript ready for submission to a peer review journal.

The program offers two concentrations in either clinical or educational practice:

• Clinical Practice Leadership Track
• Educational Practice Leadership Track

Who is the Ideal Student for this Program?

Professionals with clinical backgrounds who are interested in pursuing a career as a clinical manager or as an educator in higher education. Professionals who are interested in pursuing a career in a leadership position, either in a clinical or educational role, to improve outcomes in health care. The program delivers the advanced skills and credentialing needed to meet expectations associated with higher-level positions.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Modality: 100% online, no visits to campus required.
Total Credits: 36.
Program Completion: 24 months.

Program Highlights:

• 36 credits to complete; up to 9 credit hours are offered as electives
• Collaborate with researchers, patients, and clinicians to provide cutting-edge health care solutions
• As of June 2019, Salary.com reports an average yearly salary of $103,480 for Clinical Research Managers¹

The George Washington University's (GW) online MSHS in Clinical and Translational Research program is designed to develop the clinical and translational research capabilities of research professionals, junior faculty, and scientists. This program responds to the National Institutes of Health (NIH) vision for new approaches to developing and preparing researchers who can meet the needs of a more “translational” approach to research.

Program Outcomes:

• Develop a broad foundation and understanding of the philosophies and practices of clinical and translational research in human health.
• Lead and collaborate with other scientists, clinicians, investigators on translational research teams.
• Develop strategies for health care improvement initiatives.
• Evaluate clinical research processes and standards for protecting human subjects.
• Develop translational research proposals in collaboration with professionals from other disciplines.

¹Salary.com Salary Wizard- Do you know what you’re worth? (2017). Retrieved June 6, 2019, from Salary.com.

Modality: 100% online, no visits to campus required.
Program completion: 24 months.

Program Highlights:

• The strategic leadership emphasis of the master’s program is unique among CRA programs
• In 2001, GW was the first school to launch a master’s in clinical research administration program online
• The Washington, DC campus location allows GW to leverage government and research resources to enhance faculty knowledge and curriculum content

Designed for working clinical research professionals or those in a related field, the online MSHS in Clinical Research Administration program expands your knowledge of medical product development and clinical trial standards. Students will explore the commercial and ethical dimensions of medical innovation and prepare to lead in clinical research.

Program Outcomes:

• Master the clinical, regulatory and business requirements in the planning and conduct of a clinical trial
• Integrate research design principles with scientific, medical, regulatory and commercial requirements by creating clinical development plan sections to provide adequate benefit to risk assessments in the development of a new investigational product
• Evaluate the importance of assuring data integrity in a clinical trial and in the preparation of various clinical/regulatory documents through professional assignments such as quality checking a clinical study report

Please complete the form on this page to receive free, no-obligation program details now.

Modality: 100% online, no visits to campus required
Program completion: 24 months.

Program Highlights:

• 100% online, no on-campus residency required; complete your degree in 24 months part-time
• Developed in collaboration with regulatory affairs professionals working in the industry and governmental agencies, including the FDA and NIH
• Learn the skills to advance to leadership positions in clinical research, FDA-regulated product development, patient advocacy, quality assurance, quality control, global regulatory strategy, and public health policy

Designed for working professionals, the MSHS in Regulatory Affairs program focuses on regulatory strategy, compliance, legal and ethical issues. Examine and develop processes for product development while balancing business demands and regulatory standards. This 100% online program prepares you to manage the key elements of the regulatory process while helping drive patient-centered innovation in health care.

Program Outcomes:

• 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.
• Understand the factors that influence health care policy on a national and local level and how policies influence regulatory practice.

Please complete the form on this page to receive free, no-obligation program details now.

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 Clinical Research Administration are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost

This program is designed for anyone interested in joining the thriving clinical trials industry or a seasoned professional who wants to move up the career ladder. If you're interested in helping advance understanding of new medications, products, and therapeutic treatments, this program could be for you.

Students complete 60 credits for the BSHS program and 9 of the 60 credits will apply to the MSHS program as electives. These 9 credits are charged at undergraduate tuition rate and allow students to complete approximately 25% of MSHS program while earning the BSHS.

What you will learn:

• Apply research design principles to meet clinical research and business requirements
• Lead or be a productive member of interdisciplinary teams to ensure research success and patient safety
• Design procedures to address ethical and cultural considerations for effective and compliant clinical trial conduct
• Understand clinical, regulatory, and business dimensions of planning a successful clinical trial

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

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
• Nice credits of the MSHS in Regulatory Affairs are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost

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

What you will learn:

• Apply Good Clinical Practice (GCP) regulations to ensure clinical trials meet sponsor needs, investigator goals, and regulatory standards.
• Understand pre- and post-market requirements for medical products as governed by domestic and international law.
• Develop and manage ethical clinical trials that address cultural considerations and meet commercial needs.
• Employ business principles and lead strategic decision-making in a variety of health care roles.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

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 Clinical and Translational Research are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost

In this dual degree program, you'll learn to address ethical and cultural health care considerations through coursework in clinical research processes, clinical practices, health equity, issues in bioethics, clinical and translational research, the management of clinical trials, and more. Due to its rigor, this dual degree program is ideal for motivated, high-performing, and experienced students.

Students complete 60 credits for the BSHS program and 9 of the 60 credits will apply to the MSHS program as electives. These 9 credits are charged at undergraduate tuition rate and allow students to complete approximately 25% of the MSHS program while earning the BSHS.

What you will learn:

• 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.
• Integrate evidence-based practice into clinical and translational research.
• Develop translational research proposals in collaboration with professionals from other disciplines.
• Conduct clinical and translational research with a team of scientists, clinicians, and investigators.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

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 Clinical Research Administration are completed in the undergraduate portion of the program and charged at the undergraduate per credit cost

In this rigorous dual degree program designed for highly motivated students, you'll study clinical research processes, good clinical practices (GCP), health equity, issues in bioethics, foundations in translational research, team science and research collaboration, and more. Capstone coursework and field experience give you real-world practice applying your knowledge.

You'll also gain professional experience credits, which count toward the requirements for several certifications through the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA).

What you will learn:

• 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.
• Integrate programming, data analysis, and data manipulation skills.
• Apply social and behavioral theories to the design and evaluation of biomedical information systems and technology.
• Synthesize data to inform evidence-based patient-centered care in an ethical manner.
• Evaluate informatic analytics to support clinical decision-making, clinical research, and patient engagement.
• Propose data science interventions to improve health care delivery and outcomes.
• Create a vision for the use of information to improve the quality, safety, and efficiency of patient-centered care and public health.
• Design solutions for biomedical information problems through the application of computational and systems thinking, information science, and technology.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Program Highlights:

• 100% online, no campus visits required
• 20 total courses are required to complete your degree
• Graduate in about two years by transferring up to 60 credit hours from a regionally accredited institution
• Learn the framework for conducting clinical trials including phases of drug and device development, protocol development and data management

Make a lasting impact on health care with a Bachelor's of Science in Health Sciences (BSHS) in Clinical Research Administration from the George Washington University. Participate in clinical trial conduct to ensure new therapeutics, innovative devices, and novel treatments follow regulations and guidance — protecting patients and contributing to the rapidly growing field of health care innovation.

What you will learn:

• Create elements of a clinical development plan (CDP) incorporating scientific, medical, regulatory, and commercial requirements
• Employ strategies to address ethical and cultural considerations for effective and compliant clinical trial conduct
• Communicate effectively with diverse stakeholders, individually or in a group setting

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Program Highlights:

• 100% online, no visits to campus required
• The program requires 21 total credits and can be finished in one year
• All 21 credits can be transferred into the MSHS in Clinical and Translational Research master’s program

What you will learn:

• Compose competitive grant proposals to fund clinical research
• Apply basic, clinical, community health and health services research concepts to improve patient outcomes
• Collaborate with cross-disciplinary teams in diverse research settings

Who is the ideal student for this program?

This graduate certificate in Clinical and Translational Research is ideal if you are looking to broaden your skills and serve as a principal investigator in clinical trials. The certificate also serves as a stepping-stone for those who want to pursue the full graduate degree in Clinical and Translational Research at a later time. Upon completion of the graduate certificate, students have the opportunity to transfer all 21 credits into the MSHS in Clinical and Translational Research program.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Please click here for additional program details.

Program Highlights:

• 100% online, no visits to campus required
• The program requires 18 total credits and can be finished in 18 months
• All credits can be transferred into the MSHS in Clinical Research Administration program

What you will learn:

• Demonstrate a solid grasp of the clinical, regulatory and business requirements in the planning and conduct of a clinical trial.
• Integrate research design principles with scientific, medical, regulatory and commercial requirements by creating clinical development plan sections to provide adequate benefit to risk assessments in the development of a new investigational product.
• Evaluate the importance of assuring data integrity in a clinical trial and in the preparation of various clinical/regulatory documents through professional assignments such as quality checking a clinical study report.
• Formulate strategies to address ethical and cultural considerations for effective and compliant domestic or international clinical trial conduct, in relation to key areas such as human subject’s protection, subject recruitment/retention, data integrity and risk assessment.

Who is the ideal student for this program?

The online Graduate Certificate in Clinical Research Administration program is ideal for working clinical research professionals, or those in a related field, who wish to increase their knowledge of drug development, clinical trial conduct, monitoring, and the business, ethical and legal perspectives of the clinical research industry. Upon completion of the graduate certificate, students have the opportunity to transfer all 18 credits into the MSHS in Clinical Research Administration program.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Please click here for additional program details.

Program Highlights:

• 100% online, no visits to campus required
• The program requires 18 total credits and can be finished in 12 months
• All 18 credits can be transferred into the MSHS in Clinical and Translational Research program

What you will learn:

• Oversee clinical research at the study site level
• Ensure compliance with Good Clinical Practice (GCP)
• Use biostats and epidemiology to inform clinical practice in a research study site
• Improve the practice's potential for serving as a clinical study site

Who is the ideal student for this program?

The certificate is designed for practicing MDs, PAs, PTs, and OTs, as well as students of these disciplines and allied health professionals who want to be research partners in sponsored projects. It ensures you know how to conduct clinical trials according to applicable laws and regulations and the institutional policy that governs the research.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Program Highlights:

• 100% online, no visits to campus required
• The program requires 12 total credits and can be finished in 12 months
• Developed by regulatory affairs professionals working in governmental agencies such as the FDA and NIH
• All credits can be transferred into the MSHS in Regulatory Affairs program

What you will learn:

• Understand the framework necessary to develop an integrated understanding of regulatory affairs
• Demonstrate knowledge of development and evaluation of global regulatory strategies that support drug and biologic product development.
• Examine the regulation of medical devices through an epidemiological lens
• Understand topics such as protocol development, study design, post-marketing surveillance, evaluation and assessment of regulatory submissions

Who is the ideal student for this program?

The online Graduate Certificate in Regulatory Affairs program is ideal for healthcare professionals who are either just entering the field of regulatory affairs or who wish to increase their knowledge and skills to advance to a leadership position. This program integrates global regulatory strategy across the curriculum to equip graduates as business leaders in regulatory strategy locally and abroad. Upon completion of the graduate certificate, students have the opportunity to transfer all 12 credits into the MSHS in Regulatory Affairs program.

Classes are filling for the next term. Please complete the form to speak with an online admissions advisor today!

Please click here for additional program details.