In the Master of Science in Clinical Affairs (MSCA) program, you’ll gain a comprehensive understanding of the need for and the design, implementation, and management of clinical trials from a biomedical perspective. Throughout your clinical research courses, you’ll learn the global regulations, standards, and statutes required for the design, development, approval, performance, and reporting of clinical trials.
The clinical research degree program explores the latest in lectures, case studies, research, and articles associated with the global biomedical industry. Study materials include texts by regulatory and governmental agencies engaged in clinical trial research monitoring, coordination, and compliance. This program will prepare you with comprehensive knowledge of the field, the clinical life cycle, and the importance of careful data management. When you graduate, you’ll fully understand the critical role that clinical trial research plays in the development of biologic, device, and drug products, and be prepared to seek entry into this fulfilling field with confidence.
Program Learning Outcomes
- Employ the global regulations, standards, and GCPs involved in designing, implementing and managing clinical trials for biologics, medical devices, and drugs.
- Apply knowledge of human rights obligations, the clinical life cycle, and adverse events to the design of a clinical trial.
- Select and utilize standard biomedical clinical affairs operating policies, procedures, forms, templates, reports, and electronic records.
- Design a methodology for a clinical trial with supportive data management and data analysis.
- Write compliance documents for clinical trials.
- Conduct a clinical trial regulatory audit/inspection.
Why Choose National University?
We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 165,000 alumni worldwide.
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