The M.S. in Clinical Research Administration program is designed to provide students with the knowledge and skills required for effective clinical research administration and management. This includes a detailed understanding of the regulatory environment and the following specialized, targeted skills:
- Clinical project management
- Scientific protocol development
- Ethical and regulatory standards
- Budget management
- FDA regulatory compliance and submission preparation
- Publication in specific drug class and peer journals
- R&D/Marketing interface
- The overall management and training of new clinical research personnel
Clinical research administrator positions are found in a variety of organizations, including pharmaceutical, consumer products, healthcare, biotech, and medical device companies, as well as contract clinical research organizations (CROs), government/regulatory organizations, and university research settings.
This program is designed for students who have a broad social science or health background and little or no clinical trials experience. Specific emphasis is placed on providing state-of-the-art understanding of clinical research execution and management through analysis of the day-to-day operations in clinical testing activities. A culminating practicum provides field experiences in a clinical trial setting.
At the end of this program, students will be able to:
1. Describe basic research strategies, settings, methods, and goals of clinical research, including all aspects of the preclinical and clinical phases of clinical trials.
2. Critique the advantages and disadvantages of various study protocol designs as related to the test product and anticipated endpoints of the clinical research process.
3. Critically appraise published clinical research and interpretation of new research in the context of existing knowledge and global trends/issues.
4. Demonstrate an understanding of the interdependence of the different roles in the clinical research team, including the alliance of subjects, regulatory agencies, sponsors, and sites.
5. Identify ethical, legal, regulatory, and financial considerations that impact clinical trials.
6. Apply the essentials of Good Clinical Practice (GCP).
7. Demonstrate an understanding of how the evolution of the safety and efficacy data in drug, biological, and device developments from preclinical testing through to registration and post-marketing surveillance impact product development.
8. Demonstrate an understanding of the basic physiological and epidemiological causes and correlations of disease as they relate to clinical trial investigations.
- 33 total semester credit hours
- Core courses (30 sem. cr.)
- Capstone (3 sem. cr.)
Each course is 8 weeks in length, and there are two consecutive courses per semester. The program is offered in a prescribed sequence.