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Graduate Certificate in Clinical Research Administration: Curriculum

Curriculum Details

18 TOTAL CREDITS REQUIRED

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 the clinical research certificate program are transferable to the MSHS, so students can seamlessly matriculate into the Master’s in Clinical Research program.

Core

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.

The Clinical Research Industry integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.

Analysis and evaluation of study design strategies and current practices for major therapeutic areas of clinical research (e.g., vaccine development, cardiovascular disease, anti-infectives, CNS, etc.)

Elective – Select One

CRA 6208 International Clinical Research
CRA 6211 Monitoring, Auditing, and Oversight in Clinical Research.

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