Graduate Certificate in Clinical Research and Regulatory Administration

Offered in Partnership with Northwestern University Clinical and Translational Sciences Institute

Recent growth in clinical and translational research has heightened the need for a competent clinical research workforce in industry and academia. While government organizations re-engineer the clinical research enterprise and ensure compliance with federal regulations, pharmaceutical companies seek to improve the breadth and efficiency of clinical research and maintain quality and safety standards. As a result, pharmaceutical companies and research sites must ensure that the research process is safe, efficient and compliant. There is also focus on bringing much needed products to market in a reasonable time frame to improve patient health. These requirements demand a highly skilled clinical research team with a knowledge and skill base surrounding clinical trial management, implementation, compliance, and regulatory affairs.

Career advancement opportunities abound for the effective clinical research professional at academic medical centers, research sites, and in pharmaceutical and medical device organizations. In response to the growing need for competent professionals in the industry, Northwestern University has created a graduate certificate program in Clinical Research and Regulatory Administration (CRRA).

This four-course graduate certificate curriculum grounds professionals in the key concepts of the clinical research enterprise and allows them to focus in one of two areas of research: regulatory affairs and administration and clinical trials design and conduct. The program will enable research professionals to develop competency in these areas at the site and clinical operations levels.

Program Outcomes

At the conclusion of the graduate certificate, students will have demonstrated expertise in:

• Understanding the current regulatory environment in clinical research,
• Interpreting regulatory requirements and applying them to various roles in the clinical research and drug/device development process,
• Creating systems and processes to assure quality research outcomes, and
• Fostering a climate of excellence in clinical research and research and regulatory administration.