Clinical Trials Design & Management (Biotechnology)

Photo: Clinical Research Associate (CRA) in front of monitor

Introduction:
Clinical Trials Design & Management
(Biotechnology)

"Biotech's best days are still to come," the report concludes. "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

Bay Area Biotechnology Education

The Bay Area is home to some of the most advanced medical research in the world, and luckily, that means the biomedical employment market is booming.

Enhance your career opportunities, maintain your edge, or transition to a whole new career. Learn in an environment that provides valuable networking opportunities right in the center of Biotech Bay, a leading hub for biotechnology, pharmaceutical, and device research.

Training in Clinical Trials Design & Management

Rigorous clinical trials must be conducted on biologics, pharmaceuticals, 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 employers are often not able to provide on the job training.

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

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:
Clinical Trials Design & Management

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."

-Wikipedia

Intern Opportunities at SF State CEL

Learn how to become a lab intern and earn course points that can be applied towards tuition in CEL courses.

Clinical Trials Design & Management Brochure

Download CEL's brochure for this program.

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ARCP "New Clinical Trials Registry Law"

Thursday, September 11
6:00pm-9:00pm
UC Santa Cruz Extension
Sunnyvale

Clinical Trials Design & Management
(Biotechnology)
Information Session

Thursday, July 31
5:00pm-6:00pm
SF State Downtown Campus
835 Market Street


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