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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. 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.

See Prerequisites for Admission, Curriculum Requirements and How to Register Join our email list to stay informed about this certificate.

Courses

Required CoursesThe courses must be taken in sequential order.
Course Number Course Title Units / CEUs Delivery Options Status
PB HLTH X400.2 Introduction to Clinical Research: Clinical Trial Phases and Design 3 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 Online Canceled
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.

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 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:

  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.

You may also send the mail-in registration form with your credit card information or personal check.

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 $7,300–$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 extension-science@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.

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
Assistant Clinical Professor, School of Optometry
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.
Vice President, Business Development and Operations
Cardinal Clinical Research 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

On-Site Training

UC Berkeley Extension offers customized programs tailored to your corporate training specifications and delivered where and when you choose. Designed to fit your needs, time frame and budget, our convenient on-site training aims to increase employee performance and retention without losing precious work time. Learn more.