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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.

Additional Details

Federal Financial Aid Available:
No

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.

Curriculum Requirements

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 4.0 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:

  1. Submit the online registration, and complete your student account profile if you are a new student.
  2. Pay the nonrefundable registration fee through your shopping cart. Please allow 3–5 business days for the registration to appear in your student account.

Estimated Cost

Each course is priced individually, and you pay the course fee at the time of enrollment. The certificate has an estimated cost of $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 biotech_online@berkeley.edu 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.

Advising Services

Additional Information

UC Berkeley Extension is an approved provider of continuing education units (CEUs) by the California Board of Registered Nursing (BRN). Provider 00226.

All courses in this certificate are also accepted by the Association of Clinical Research Professionals (ACRP) toward fulfillment of the maintenance requirements for ACRP certification.

Advisory Board

Jane M. Alexander, B.S.N., M.P.H.
Associate Director, Clinical Operations
Ilypsa Inc.

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)
UC Berkeley

Madeline Miller, D.V.M, M.S.
Executive Vice President and Chief Operating Officer
BioSoteria Inc.

Kenneth A. Polse, O.D., M.S
Professor of the Graduate School
Berkeley Clinical Scientist Development Program Director, School of Optometry
UC Berkeley

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

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
ACRP