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. UC Irvine Extension's 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 Attend

• 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

Individuals seeking the designation of Certified Clinical Research Professional, “CCRP,” from The Society of Clinical Research Associates (SoCRA), who hold an Associate's Degree or Bachelor’s degree in science, health science, pharmacy, or a related (science/
healthcare) field, may complete the UC Irvine Extension 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 Web site.

Certificate 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 point average of “B” or better. An Application for Candidacy must be submitted before the completion of the third course in the program. Note: Six credit units may be counted toward the Medical Product Development Certificate Program.

All requirements must be completed within five (5) years after the student enrolls in his/her first course.

On-site Training Available

Through Corporate Training, we 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 UC Irvine Extension (classroom and online formats) require professional-level English language proficiency in listening and note-taking, reading comprehension and vocabulary, written expression, and oral presentation. If you would like to refine your English language proficiency prior to beginning one of our programs, please see our English Language Programs.

Stay Informed About
Clinical Trials: Medical Device and Drug Development

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.
• Earn credits to qualify for RAC recertification. UC Irvine Extension is a RAPS registered provider for professional development.
• Learn from instructors seasoned in practical industry experience who share their knowledge effectively.

Transfer Credit

Graduates from UC Irvine Extension’s Clinical Trials program are eligible to transfer credits to Keck Graduate Institute’s Masters of Bioscience program; and Northeastern University’s Master of Regulatory Affairs program.

Advisory Committee

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

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