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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.

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 United States.

110,656
Jobs
(2016)
10.80%
Projected Growth
(2017-2027)
$57k-$116k
Annual Salary
(25th-75th Percentile)

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
  • UCI Division of Continuing Education is a Regulatory Affairs Professional Society (RAPS) professional development provider
  • Earn credits to qualify for RAC recertification
  • Learn from instructors seasoned in practical industry experience who share their knowledge effectively

Darren shares how getting a Clinical Trials Certificate has helped advance his career. Read Article

Course Schedule

Required Courses

TitleWinterSpringSummerFall
EECS X445.2
Regulatory Requirements for Medical Devices (3 units)
EECS X445.2
to be scheduled to be scheduled   Online
EECS X445.2 OR EECS X445.26

EECS X445.2 OR EECS X445.26
EECS X445.26
Regulatory Requirements for Pharmaceutical Products (3 units)
EECS X445.26
  to be scheduled Online Online
BIO SCI X450
Fundamentals of Clinical Trials (3 units)
BIO SCI X450
to be scheduled   Online  
MED X413.4
Application of Good Clinical Practices (3 units)
MED X413.4
    Online  
BME X430
Human Subjects Safety in Clinical Trials (2 units)
BME X430
to be scheduled      

Elective Courses

TitleWinterSpringSummerFall
Clinical Trials
BME X405
Applied Anatomy and Physiology for Clinical Studies (4 units)
BME X405
      Online
MED X413.41
Good Laboratory Practices (1.5 units)
MED X413.41
      Online
MED X413.43
Clinical Data Management (1.5 units)
MED X413.43
  to be scheduled    
MED X413.44
Clinical Trials Internship (3 units)
MED X413.44
       
MED X413.45
Clinical Trials Project Management (3 units)
MED X413.45
    Online  

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. Students are encouraged to declare candidacy as soon as possible, but no later than after the third course in the program. To receive the 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.

Breaking into the Business of Regulatory Affairs & Biotechnology (4/11/18)

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. Call Dave Dimas at (949) 824-5380 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.

Advisory Committee

  • Amy L. Batoosingh, Sr. Director, Core Project Team Lead, Allergan, Inc.
  • Patricia Beers Block, B.S., B.S., CCRP Assistant Professor, Clinical Trial Sciences BioPharma Educational Initiative, SHP 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.

RAPS Professional Development provider
UCI Division of Continuing Education is a Regulatory Affairs Professionals Society (RAPS) Professional Development provider. UCI Division of Continuing Education is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs UCI Division of Continuing Education has agreed to follow RAPS’ established operational and educational criteria.