The MCR program prepares graduates to excel as research administrators, regulatory compliance specialists and other professional roles on clinical research teams.
The program offers a multidisciplinary curriculum, covering the science and practice of research methods, medical product regulation, research ethics, pharmacology, statistics, and research operations and management.
All students complete a culminating project in their final semester where they have an opportunity to apply best practices in clinical research administration. Students who are novice to clinical research may elect to complete a self-arranged practicum in conjunction with the culminating project.
This 100 percent online program is designed to be flexible and convenient to students at the career-entry or mid-career level. Applicants with any undergraduate degree are welcome. The program is especially well suited for graduates with a degree in the life sciences or pharmaceutical sciences, health care professionals, and those with graduate degrees in the biomedical sciences seeking to diversify their training.
MCR courses are offered online through Ohio State's Learning Management System, Carmen. Test drive a sample online course by visiting the Ohio State Online website.
The MCR program is designed with a set of core courses covering the application of clinical research principles and a set of specialization courses providing in-depth learning in an area of focus chosen by the student. The program requires 36 credit hours of coursework that may be completed on either a full- or part-time schedule in 12-24 months (12-month option available for students entering in autumn only).
As a final master’s activity, all students compile an ePortfolio of work showcasing their achievements in each of the eight Joint Task Force Clinical Trial Competency Domains. The MCR degree does not require a thesis or a comprehensive master’s exam.
There are two course options offered:
Clinical Research Management Specialization:
The Clinical Research Management Specialization focuses on the management of systems and processes in the conduct of clinical trials to prepare graduates to lead complex national and international clinical research operations. Graduates of this track will have attained the skills to work as Clinical Research Coordinators (CRCs) or Clinical Research Associates (CRAs) representing the study sponsor or investigation site and to advance their careers as clinical research administrators.
Regulatory Affairs Specialization:
The Regulatory Affairs Specialization emphasizes the assurance of the safe and effective medical product development and use throughout the product life cycle through regulatory oversight and strategy. Graduates from this track will have the skills to interpret FDA and international agencies' regulations and guide regulatory strategy and operations. Regulatory compliance professionals work in many settings, including government, industry, clinical research organizations, and academic institutions.
On completion of the core coursework in the MCR program, students will have attained competencies as defined by the Consortium of Academic Programs in Clinical Research and the Joint Task Force for Clinical Trial Competency:
• Scientific Concepts and Research Design
• Ethical and Participant Safety Considerations
• Medical Product Development and Regulation
• Clinical Trials Operations; Good Clinical Practices
• Study and Site Management
• Data Management and Informatics