Students in the online Graduate Certificate in Clinical Research Administration (CRA) program must successfully complete 15 credit hours in CRA, and a 3 credit hour elective.
All courses in this program are transferable to Master of Science in Health Sciences (MSHS) in CRA.
Clinical Research Administration Courses
Students develop the academic skill sets necessary to succeed in this program in the context of exploring scientific, clinical and regulatory concepts required in medicines development. Students demonstrate their critical analysis skills through literature research, analysis of information from various perspectives, and formulating their own opinions in choosing their ‘defendable positions’, rather than stating the “correct answers”.
This course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.
This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.
This course integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.
This course explores how to manage risk and safety assessments to ensure quality in clinical research.