Clinical Trials Design & Management (Biotechnology)

Professional Development Certificate

What is Clinical Trials Design & Management?

Rigorous clinical trials must be conducted on pharmaceuticals, biologics and devices by sponsor organizations prior to applying for approval to market these products to the public. The work is fast-paced, and the regulations and market change constantly. The industry needs trained professionals, and our program delivers the necessary skilled workforce.

We are located in the heart of San Francisco and Biotech Bay where sponsor organizations, public agencies, and clinical investigators in medical centers and private practice care for clinical trials subjects. Enroll now to enhance your career opportunities, or transition into a whole new career.

Biotech's best days are still to come. It is an industry of fundamentally sound companies creating essential products for improving the health and quality of life of everyone on the planet.

Ted Agres, Deputy Managing Editor, Washington Times

California Biomedical Industry Report Highlights

Number of California biomedical companies: 2,323
Total estimated revenue: $115.4 billion
Total estimated employment: 267,271
Total estimated wages and salaries: $20.4 billion
Average annual biomedical industry wage: $76,495
Total NIH grants awarded: $3.2 billion
Total estimated venture capital investment in California biomedical companies: $2.7 billion
Total biomedical exports: $18.6 billion

The Clinical Trials Design & Management Program

SF State Extended Learning is dedicated to the ongoing training and development in this growing field. Our courses are taught by active industry professionals who demonstrate a deep level of commitment to their students and the industry at large.

Learn in an environment that provides valuable networking opportunities while learning the design implementation and regulation of all phases of clinical trials.

Bay Area Biotechnology Education

We are located in the heart of San Francisco and the SF Bay Area where sponsor organizations, public agencies, and clinical investigators in medical centers and private practice, care for trials subjects.

Certificate Education & Training

Individuals who pursue a Clinical Trials Design & Management certificate from San Francisco State University's College of Extended Learning are professionals, often with advanced degrees, working in science, health care, technology, or management. Enroll now to transition into your new career.

Students may complete a full certificate or simply take those courses which advance their own professional goals. The Program is designed to be flexible for working adults by offering evening or weekend courses.

Professional Biotechnology Faculty

We continue to add new courses upon request of employers and enrollees. We are interested in additional instructors who are working professionals wanting to share their area of expertise. Qualifications include teaching skills and academic excellence.

What is a Clinical Research Associate (CRA)?

"A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP).

The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex.



CSU-wide information on biotechnology education: To better publicize biotechnology programs and timely industry-specific courses, the California State University (CSU) has gathered information here about relevant degree programs and courses offered at CSU campuses.

Clinical Development Online Courses

Extended Learning also offers online courses in Clinical Development.