Laura Castellini is a senior scientist at CCS Associates Inc.
There is growing demand for qualified clinical researchers to conduct trials on medical treatments and devices. With this certificate, you will master the practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, and quality control and assurance. You will also become familiar with the legal and ethical side of clinical research, including FDA regulations and ICH guidelines, compliance and bioethics. An advisory board of academic and industry leaders monitors the curriculum. Courses are available online or in a hybrid classroom/online format.
There are no prerequisites for the Certificate Program in Clinical Research Conduct and Management, but a bachelor's degree is recommended, preferably in a science or technical field.
The curriculum comprises 4 required courses for a total of 12 semester units (180 hours of instruction). Candidates must pay a nonrefundable certificate registration fee.
The Certificate Program in Clinical Research Conduct and Management is taught in both a hybrid format that consists of 50 percent classroom instruction and 50 percent online instruction and a fully online format. You can move freely between the two formats as long as all four courses are completed in sequential order.
You must take all courses for a letter grade. To receive the certificate, you must complete all courses with a grade of C or better. The certificate can be completed in two semesters (one year). All coursework must be completed within five years.
By registering, you declare your intention to complete the curriculum. To register online for the Certificate Program in Clinical Research Conduct and Management, complete these two steps:
Each course is priced individually, and you pay the course fee at the time of enrollment. The certificate has an estimated cost of $8,210 (not including registration fee). Course fees are subject to change.
Once you have completed the certificate coursework, notify UC Berkeley Extension that you have completed the curriculum and request your certificate. Send an email to biotech_online@berkeley.edu. After your records have been reviewed, verified and approved (usually within two to three weeks), your certificate will be mailed to you.
Networking and Career Growth in Biosciences and Biotechnology Panel
The current certificate program curriculum totals 180 instructional hours. Students may apply these hours and/or elect to take additional coursework to replace a portion of the total work experience hours needed to meet eligibility requirements to apply for the Certified Clinical Research Professional Certification by the Society of Clinical Research Associates (SOCRA). Students may also opt to apply course credit from this certificate program toward maintenance of their certification through the Association of Clinical Research Professionals (ACRP) organization.
Susan Carino, M.B.A., M.S., PMP, RAC
Principal Consultant, Integrated Project Management Company, Inc.
Chair, SF Bay Area Regulatory Affairs Professionals Society
Victor Chen
Managing Director, Clinical Trials Program
Kaiser Permanente, Northern California Division of Research
Philippe Forgues, M.S.
VP of Clinical Operations and Data Management
Kite Pharma
Suzanne Haendel, J.D., C.L.P.
Director, Technology Transfer Office
Children's Hospital and Research Center, Oakland
Karen A. Henry, BBA, M.P.H.
Clinical Operations Consultant
Advanced Clinical Services
Arthur Reingold, M.D.
Professor and Head of Epidemiology
Associate Dean for Research
School of Public Health
UC Berkeley
Charles Schwamlein, M.D., M.P.H.
Drug Safety Consultant
Na Zhang, Ph.D.
Director, Clinical Affairs
Visby Medical, Inc.