The MACPR 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 credits 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). The program concludes with a culminating project. Students who are novices in clinical research may elect to complete a self-arranged practicum in conjunction with their culminating project.
All MACPR students will complete the following core courses to build a solid foundation in the theory and conduct of clinical research.
- Core courses
Responsible Conduct of Research
Fundamentals of Medical Product Development and Regulation
Clinical Research Design and Methods
Clinical Research Study and Site Management
Nursing/Pharmacy 7482 Principles of Quality Management for Medical Product Development
Data Analysis and Interpretation in Clinical and Preclinical Research
Fundamentals of Pharmacology
*Pharmacology is required only for students without prior pharmacology coursework at the graduate or upper undergraduate level.
You may select from one of two specializations in the MACPR program:
- Clinical Research Management
- Regulatory Affairs
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.
- Clinical Research Management specialization courses
In addition to the core coursework, students in the Clinical Research Management Specialization will complete the following courses:
Required specialization courses:
Nursing 7404 Project Management for Healthcare and Clinical Research Nursing 7481 Data Management and Informatics in Clinical Research Nursing 7482 Principles of Quality Management for Medical Product Development Nursing/Pharmacy 7599 Culminating Project in Clinical Research
Select two of the following:
Pharmacy 5005 Fundamentals of Pathophysiology Nursing 7402 Economic Evaluation of Healthcare Interventions CBG/Pharmacology 5700 Introduction to Personalized Therapeutics and Pharmacogenomics Pharmacy 7570 Pharmaceutical Safety & Risk Management Pharmacy 7460 Regulatory Strategy and Clinical Trial Reporting Pharmacy 7572 Global Regulation of Medical Products
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.
- Regulatory Affairs specialization courses
In addition to the core coursework, students in the Regulatory Affairs Specialization will complete the following courses:
Required specialization courses:
Nursing/Pharmacy 7460 Regulatory Strategy, Writing and Leadership Pharmacy 7570 Pharmaceutical Safety & Risk Management Pharmacy 7572 Federal Regulations of Medical Products
Culminating Project in Clinical Research
Select one of the following:
Nursing 7481 Data Management and Informatics in Clinical Research Pharmacy 7580 Principles of Safety Pharmacology Nursing 7404 Project Management for Healthcare and Clinical Research
On completion of the core coursework in the MACPR 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
- Leadership and Professionalism
- Communication and Teamwork
Additional skills will be gained in the student’s chosen area of specialization through courses taught by faculty and practicing clinical research professionals with expertise in these areas.
If you have questions about this program, please reach us at firstname.lastname@example.org.