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Clinical Trials: Medical Device and Drug Development

UCI Division of Continuing Education is approved by the California Board of Registered Nursing (BRN) for contact hours (provider number 00093).

Overview

Demonstrating the effectiveness and safety of new medical products is a critical part of the medical product development process and requires significant resources to accomplish. Our program fills a growing need for professional learning that ensures designing and implementing clinical trials for success. The curriculum provides comprehensive knowledge of coordinating, monitoring and managing a clinical trial within a framework of good clinical practices and regulatory requirements. An internship course provides an invaluable capstone experience for the certificate.


Members save 10% on one
UCI DCE course per quarter.

Who Should Enroll

  • Working professionals who are interested in transitioning into the clinical trials arena
  • Nurses interested in expanding their career options
  • Researchers and technologists seeking to increase earning power in the clinical research field
  • Medical product development professionals who need working knowledge of clinical trials
  • Healthcare professionals and allied health professionals

Career Insight

Occupational summary for medical scientists in the US.

134,975
Annual Job Openings
(2019)
13.9%
Projected Growth
(2019-2029)
$83k
Median Salary
(Highly experienced workers can earn up to $154k)
Life Science Industry in Orange County

Program Benefits

  • Gain the knowledge base needed to design and implement effective clinical trials.
  • Acquire a comprehensive knowledge of laws, regulations, guidance, and standard practices needed to surpass regulatory requirements
  • Improve time-to-market by applying approved clinical research regulations and clinical research guidelines
  • Learn from instructors seasoned in practical industry experience who share their knowledge effectively

Course Schedule

Required Courses

TitleWinterSpringSummerFall
EECS X445.2
Regulatory Requirements for Med Devices (3.00 Units)
EECS X445.2
Online Online   to be scheduled
EECS X445.2 OR EECS X445.26

EECS X445.2 OR EECS X445.26
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3.00 Units)
EECS X445.26
  Online to be scheduled to be scheduled
BIO SCI X450
Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
Online   to be scheduled  
MED X413.4
Application of Good Clinical Practices (3.00 Units)
MED X413.4
  Online    
BME X430
Human Subjects Safety in Clinical Trials (2.00 Units)
BME X430
Online      

Elective Courses

TitleWinterSpringSummerFall
Clinical Trials
BME X405
Applied Anatomy and Physiology for Clinical Studies (4.00 Units)
BME X405
      to be scheduled
MED X413.41
Good Laboratory Practices (1.50 Units)
MED X413.41
      to be scheduled
MED X413.43
Clinical Data Management (1.50 Units)
MED X413.43
  Online    
MED X413.44
Clinical Trials Internship (3.00 Units)
MED X413.44
       
MED X413.45
Clinical Trials Project Management (3.00 Units)
MED X413.45
    to be scheduled  

Course schedules are subject to change. Individual courses may be taken without enrolling in the full certificate.

Receive Customized Training for your Employees

For course prerequisites and estimated program pricing, please refer to the program brochure.

Learn How To Earn Your CertificateCertificate Eligibility and Requirements

A certificate is awarded upon completion of 16 credit units (11 required and a minimum of 5 elective credit units), with a grade of “C” or better in each course. Note: Six credit units may be counted toward the Medical Product Development Certificate Program when courses are shared.

To become an official candidate in the program, students pursuing the certificate must submit a Declaration of Candidacy with a non-refundable $125 application fee. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the digital certificate after completing all program requirements, students must submit a Request for Certificate. All requirements must be completed within five (5) years after the student enrolls in his/her first course. Students not pursuing a certificate are welcome to take as many individual courses as they wish.

Certified Clinical Research Professional (CCRP)

Individuals seeking this designation from The Society of Clinical Research Associates (SOCRA), and who hold an Associate’s Degree or Bachelor’s degree in science, health science, pharmacy, or a related (science/healthcare) field, may complete the Clinical Trials Certificate Program in lieu of one year of SOCRA’s eligibility requirement of two years’ work experience in clinical research. For more information about the CCRP designation, please visit the SOCRA Website.

Internship course available to students who are certificate candidates and have completed the required courses. Email kheck1@uci.edu for details.

Transfer Credit

Graduates from UCI Division of Continuing Education’s Clinical Trials program are eligible to transfer credits to:

Note: Any student wishing to transfer credits must obtain a “B” or better in each course.

Clinical Trials Information Session
Recorded 3/11/20
View Webinar

Advisory Committee

  • Amy L. Batoosingh, Sr. Director, Core Project Team Lead, Allergan, Inc.
  • Patricia Beers Block, Faculty, Biopharma Initiatives Program, Rutgers the State University of New Jersey
  • Ginger Clasby, Vice President, Clinical Affairs, Transcend Medical
  • Maribelle Guloy, Director of Early Clinical Development Clinical Operations at WCCT Global/Medelis
  • Ruth Mulnard, Associate Professor of Nursing Science, Associate Director, University of California, Irvine
  • Richard Nichol, President, Nichol Clinical Technologies Corp.
  • Yutaka Niihara, MD, CEO, Emmaus Life Sciences, Inc.
  • Albert Rego, Scientific Consultant to the Life Science Industry
  • Nancy Schwartz, Principal, SearchLight Consulting
  • Charles Stark, PharmD, Sr VP, Research and Development, Emmaus Life Sciences, Inc.
  • John Thropay, President & Medical Director, Beverly Oncology & Clinical Trials & Research Associates, Inc.

On-site Training Available

Our Corporate Training specialists can deliver this program or customize one that fits your organization’s specific needs. Visit Corporate Training or call (949) 824-1847 for information.

English Proficiency Requirement
All certificate programs at UCI Division of Continuing Education (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation.