Before new drugs, biologics or medical devices reach the market, it enters a clinical research trial to investigate whether the new treatment or device is safe and effective for humans. As more funds are funneled into the development of new drugs, the need for qualified clinical researchers to conduct and administer these projects will continue to grow. With this certificate, you will master practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, FDA regulations and ICH guidelines, data management and analysis, operations, global studies, quality control and assurance, compliance and bioethics.

Take courses either online or in a hybrid classroom/online format, learning from instructors who bring their extensive experience into the classroom. The curriculum is overseen by an advisory board comprised of academic and industry leaders.

Once you’ve completed the certificate, consider securing an internship to gain practical work experience. You can apply to the Stanford Clinical Research Preceptor Program to gain first-hand knowledge by shadowing with a preceptor in the Stanford School of Medicine. Or consider interning in the pharmaceutical or medical devices/in vitro diagnostics industry through our connections in the San Francisco Bay Area. Inquire by emailing biotech_online@berkeley.edu.