The human testing process, also known as a clinical trial, determines whether a drug, biologic or medical device is safe and effective before approval for marketing and sale. Regulations and guidelines govern the clinical trials process; thus, thorough knowledge of the procedures at every stage is essential. The Certificate Program in Clinical Research Conduct and Management—available either online or in a hybrid classroom/online format—enables you to master practical aspects of clinical trial conduct and management, including clinical trial phases and design, planning, implementation, data analysis, regulatory and procedural guidelines, and ethical considerations. The curriculum is overseen by an advisory board of life-science and education leaders and approved by the University of California, Berkeley, College of Letters and Science, ensuring your education is relevant and up to date. Courses are taught by working professionals with many years of practical experience. Coursework in this certificate also meets continuing education requirements for nurses and clinical research professionals.
|Course Number||Course Title||Units / CEUs||Delivery Options||Status|
|PB HLTH X400.2||Introduction to Clinical Research: Clinical Trial Phases and Design||3||Hybrid, Online||Available|
|PB HLTH X400.3||Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities||3||Hybrid, Online||Available|
|PB HLTH X400.4||Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting||3||Hybrid, Online||Available|
|PB HLTH X400.5||Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management||3||Hybrid, Online||Available|
Course availability is subject to change. Courses offered in both online and classroom environments are interchangeable; if both delivery options are available, you may choose either option.
To enroll, click on a course title above and choose a section. You may enroll in individual courses without registering for a certificate or program.
Prerequisites for Admission
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 maintain an overall minimum 2.5 grade point average, with a grade of C or better in each course. A Certificate with Distinction will be awarded to those who complete the certificate with a GPA of 3.9 or higher. The certificate can be completed in two semesters (one year). All coursework must be completed within five years of registering for the certificate.
How to Register
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:
- Submit the online registration, and complete your student account profile if you are a new student.
- Pay the nonrefundable registration fee through your shopping cart.
You may also send the mail-in registration form with your credit card information or personal check.
Each course is priced individually, and you pay the course fee at the time of enrollment. The certificate has an estimated cost of $7,300–$7,580 (not including registration fee). Course fees are subject to change.
Certificate and Award Request
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 firstname.lastname@example.org or call (510) 642-1062. After your records have been reviewed, verified, and approved, your certificate will be sent to you in the mail. The review of your records is usually completed within six to eight weeks after you request the certificate.
Jane M. Alexander, B.S.N., M.P.H.
Associate Director, Clinical Operations
Lincoln Bynum, M.D.
Vice President, Medical Consulting and Product Development Services
ICON Clinical Research
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
Meng C. Lin, O.D., Ph.D., FAAO
Associate Professor, Clinical Optometry and Vision Science
Director, UC Berkeley Clinical Research Center (CRC)
Madeline Miller, D.V.M, M.S.
Executive Vice President and Chief Operating Officer
Kenneth A. Polse, O.D., M.S
Professor of the Graduate School
Berkeley Clinical Scientist Development Program Director, School of Optometry
Arthur Reingold, M.D.
Professor and Head of Epidemiology
Associate Dean for Research
School of Public Health
Charles Schwamlein, M.D., M.P.H.
Drug Safety Consultant
Beverly D. Smolich, Ph.D.
Biotechnology R&D Consultant
Helen Street, M.S., RN
CEO, Clinical Research
H Street Consulting
Mariana Tran, M.B.A., Ph.D.
Senior Program Manager
Otsuka Pharmaceutical Development & Commercialization, Inc.
Liz Wool, BSN, CCRA, CMT
President and CEO
QD-Quality and Training Solutions, Inc.
Board of Trustees
Association of Clinical Research Professionals (ACRP)
Editorial Advisory Board
ACRP Monitor magazine
President, Northern California Chapter