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Clinical Trials: Medical Device and Drug Development

Certificate Program Online!

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.

Who Should Enroll

  • 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
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.

Certificate Eligibility and Requirements

A certificate is awarded upon completion of 16 credit units (10.5 required and a minimum of 5.5 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.

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.

Stay Informed About
Clinical Trials: Medical Device and Drug Development

Clinical Trials - Medical Device & Drug Development: Information Session
Recorded 12/15/15
View Webinar

Program Benefits

Valerie Sanchez
  • 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 RAPS registered provider for professional development
  • Earn credits to qualify for RAC recertification
  • Learn from instructors seasoned in practical industry experience who share their knowledge effectively

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, Director, Clinical Research, Allergan, Inc.
  • Ginger Clasby, Vice President, Clinical Affairs, Transcend Medical
  • Maribelle Guloy, Director, Clinical Trials, Clinical Trials & Research Associates, Inc.
  • Ruth Mulnard, Associate Professor of Nursing Science, Associate Director, University of California, Irvine
  • Richard Nichol, President, Nichol Clinical Technologies Corp.
  • Albert Rego, Scientific Consultant to the Life Science Industry
  • Nancy Schwartz, Principal, SearchLight Consulting
  • John Thropay, President & Medical Director, Beverly Oncology & Clinical Trials & Research Associates, Inc.

Orange County Regulatory Association (OCRA)
members receive a 10% discount