MCR Curriculum
Time to degree: 1 year of full-time study or 2 years of part-time study, including summers
Number of credits: 30 credit hours
Educational delivery format: The classes are available online asynchronously, meaning there are no mandatory "live" online lectures or discussions. Module lectures are recorded from our esteemed faculty or outside experts in the field, and you can view and participate at your convenience. Some of our classes might offer occasional “live” presentations. You will be notified in advance and can choose to watch live or view a recording later.
You may select from one of two specializations in the MCR program:
- Clinical Research Management
- Regulatory Affairs
Clinical Research Management Specialization
The Clinical Research Management Specialization focuses on the management of operations, systems and processes in the conduct of clinical trials to prepare graduates to lead complex national and international clinical research infrastructures. Graduates of this track will have attained the skills to work as Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs) and additional higher-level positions representing the study sponsor or investigation site and to advance their careers as clinical research professionals.
- Clinical Research Management specialization courses
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In addition to the core coursework, students in the Clinical Research Management Specialization will complete the following courses:
Required specialization courses:
- Project Management for Healthcare and Clinical Research
- Data Management and Informatics in Clinical Research
- Research Leadership, Administration and Finances
- Culminating Project in Clinical Research
Regulatory Affairs Specialization
Regulatory Affairs is an expanding area in medical product development in the U.S. and globally. Regulatory Affairs professionals represent a diverse array of roles, with the commonality of being a key point of contact between companies and regulatory bodies such as the U.S. FDA. Areas of focus are vast and may include quality assurance, clinical trial reporting (e.g., regulatory writing), medical product development and promotional review.
Coursework in the Regulatory Affairs Specialization emphasizes the assurance of the safe and effective medical product development and use throughout the product life cycle – from conception to commercialization. Topics in the specialization cover regulatory strategy during medical product development, regulatory oversight and documentation and report generation. Graduates from this track may work in many settings, including academic institutions, government, pharmaceutical companies, institutional review boards (IRBs) and clinical research organizations (CROs).
- Regulatory Affairs specialization courses
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In addition to the core coursework, students in the Regulatory Affairs Specialization will complete the following courses:
Required specialization courses:
- Regulatory Strategy, Writing and Leadershi
- Federal Regulations of Medical Products
- Data Management and Informatics in Clinical Research
- Culminating Project in Clinical Research
Full-Time Plan of Study:
- Year 1
-
Autumn
- Fundametals of Medical Product Development and Regulation (3 credits)
- Clinical Research Design and Methods (3 credits)
- Responsible Conduct of Research (3 credit hours)
- Clinical Research Study Management and Monitoring (3 credits)
Spring
- Pharmacology for the Non-Clinician (3 credits)
- Principles of Quality Management for Medical Product Development (3 credits)
- Specialty Coursework (3 credits)
- Data Management and Informatics (3 credits)
Summer
- Specialty Coursework (3 credits)
- Culminating Project in Clinical Research
Part-Time Plan of Study:
- Year 1
-
Autumn
- Fundamentals of Medical Product Development and Regulation (3 credits)
- Responsible Conduct of Research (3 credits)
Spring
- Pharmacology for the Non-Clinician (3 credits)
- Data Management and Informatics (3 credits)
Summer
- Specialty Coursework (3 credits)
- Principles of Quality Management for Medical Product Development ( 3 credits)
- Year 2
-
Autumn
- Clinical Research Design and Methods (3 credits)
- Clinical Research Study Management and Monitoring (3 credits)
Spring
- Specialty Coursework (3 credits)
- Culminating Project in Clinical Research (3 credits)
Core Competencies
- Scientific Concepts and Research Design
- Ethical and Participant Safety Considerations
- Investigational Product Development and Regulation
- Clinical Study Operations (Good Clinical Practice)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communications and Teamwork
The MCR program was the second graduate clinical research program in the United States accredited by CAAHEP. All MCR students attain applied competencies as defined by the Joint Task Force for Clinical Trial Competency.
