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  • Berkeley Global

Certificate Program in Clinical Research Conduct and Management

Jennifer Brandl
is Senior Clinical Trial Manager at Kezar Life Sciences.

Graduate, Certificate Program in Clinical Research Conduct and Management
Read Jennifer Brandl's Story

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.

After completing the certificate, you can apply to internships to gain practical work experience. Apply to the Stanford Clinical Research Preceptor Program to shadow a preceptor at the Stanford School of Medicine. Or consider interning in the pharmaceutical, medical devices, or in vitro diagnostics industries through our connections in the San Francisco Bay Area. Email biotech_online@berkeley.edu for more information.

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Live Online format allows you to take classes from anywhere with an internet connection. Classroom sections will be taught in this format through Spring 2021. Learn more about this format.

Beginning August 15, 2020, you must have a Zoom account to participate.

Many schools are now accepting transfer credit for online coursework, including health and sciences programs. Check with your institution before enrolling.

Courses

Required Courses

Expand or collapse Required Courses
Minimum Required

4 Course(s)

Maximum Allowed

0 Course(s)

The courses must be taken in sequential order.

  • PB HLTH X400.2 Introduction to Clinical Research: Clinical Trial Phases and Design
    Units / CEUs

    3

    Delivery Options

    Online

    Status

    Available

  • PB HLTH X400.3 Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
    Units / CEUs

    3

    Delivery Options

    Online, Hybrid

    Status

    Available

  • PB HLTH X400.4 Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
    Units / CEUs

    3

    Delivery Options

    Online

    Status

    Available

  • PB HLTH X400.5 Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management
    Units / CEUs

    3

    Delivery Options

    Online, Hybrid

    Status

    Available

Courses of Related Interest

Expand or collapse Courses of Related Interest
Minimum Required

0 Course(s)

Maximum Allowed

0 Course(s)

Take additional courses from this list to bolster your knowledge in select science topics to advance your career. These optional courses are available if you are interested in applying educational hours toward eligibility for the Association of Clinical Research Professionals (ACRP) Clinical Research Associate credentialing exam.
  • MCELLBI X410.1 Pharmacology
    Units / CEUs

    3

    Delivery Options

    Online

    Status

    Available

  • MCELLBI X413 Genomic Medicine
    Units / CEUs

    3

    Status

    Not Available

  • MCELLBI X419 Principles of Toxicology
    Units / CEUs

    3

    Status

    Not Available

  • MCELLBI X471 Introduction to Biostatistics
    Units / CEUs

    3

    Delivery Options

    Online

    Status

    Available

  • PB HLTH 1023 The Drug Development Process: An Intensive Seminar
    CEUs

    3.6

    Delivery Options

    Online

    Status

    Available

  • MCELLBI X431 Principles of Product and Process Development
    Units / CEUs

    1

    Status

    Not Available

  • PB HLTH X401.6 Principles of Quality and Compliance
    Units / CEUs

    1

    Delivery Options

    Online

    Status

    Available

From Junior Biologist to Senior Medical Writer

“[Enrolling in the Certificate Program in Clinical Research Conduct and Management] was probably the best decision I've made in my life—I am not exaggerating. I have my current job literally... continue reading From Junior Biologist to Senior Medical Writer

Continue Reading this Post

Certificate and Program Policies

  • Substitutions and Waivers
  • Transfers
  • Financial Aid
  • Transcripts and Records

Program Staff

Elissa Carney
Elissa Carney
Program Director

Contact Us

To contact the department office, email biotech_online@berkeley.edu.

 

65% of graduates surveyed chose the Clinical Research Conduct and Management certificate to make a career change; 60% secured a job within a year of completing the courses.

 

80% of graduates surveyed felt prepared for professional credentialing (such as CCRA®, CCRP) upon completing the certificate.

 

81% of our graduates would recommend this certificate.

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.

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 $8,210 (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 (usually within two to three weeks), your certificate will be mailed to you.

Introducing: Career Services!

You have worked on your Berkeley academics and are now planning the next stage of your professional life, but you don't know where to start. Let the Berkeley Global Career Services team support you in taking your next steps! Get started today.

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Additional Information

Courses in this certificate program are accepted by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SOCRA), and can be used to fulfill a portion of the work experience hours requirement for credentialing exam eligibility.

Advisory Board

Susan Carino, M.B.A., M.S., PMP, RAC
Principal Consultant, Integrated Project Management Company, Inc.
Vice 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.
Principal Clinical Research Scientist
Clinical Affairs
Cepheid

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