Jennifer Brandl
is a Clinical Trial Manager at Portola Pharmaceuticals.

Class of 2013, Certificate Program in Clinical Research Conduct and Management
Read Jennifer Brandl's Story

 

Online Availability

Courses in this certificate are offered online and in the classroom.

 

Duration of Study

The certificate can be completed in two semesters (one year).

 

Estimated Cost

$7,900

Before new drugs, biologics or medical devices reach the market, it enters a clinical research trial to investigate whether the new treatment or device is safe and effective for humans. As more funds are funneled into the development of new drugs, the need for qualified clinical researchers to conduct and administer these projects will continue to grow. With this certificate, you will master practical aspects of running and managing a clinical trial, including trial design and phases, good clinical practices, the drug discovery and development process, FDA regulations and ICH guidelines, data management and analysis, operations, global studies, quality control and assurance, compliance and bioethics.

Take courses either online or in a hybrid classroom/online format, learning from instructors who bring their extensive experience into the classroom. The curriculum is overseen by an advisory board comprised of academic and industry leaders.

 

Once you’ve completed the certificate, consider securing an internship to gain practical work experience. You can apply to the Stanford Clinical Research Preceptor Program to gain first-hand knowledge by shadowing with a preceptor in the Stanford School of Medicine. Or consider interning in the pharmaceutical or medical devices/in vitro diagnostics industry through our connections in the San Francisco Bay Area. Inquire by emailing biotech_online@berkeley.edu.

Prerequisites

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 $7,900 (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.

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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

Suzanne Haendel, J.D., C.L.P.
Director, Technology Transfer Office
Children's Hospital and Research Center, Oakland

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

Karen A. Henry, BBA, M.P.H
Clinical Operations Consultant
Advanced Clinical Services

Philippe Forgues, M.S.
Senior Director, Clinical Operations
Relypsa, Inc.

Na Zhang, Ph.D.
Clinical Research Associate
Medical & Scientific Affairs
Roche Molecular Systems, Inc.

Victor Chen
Director, Clinical Affairs
Align Technology, Inc.