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
- Medical product development professionals who need working knowledge of clinical
- Healthcare professionals and allied health professionals
Certified Clinical Research Professional
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 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.
Clinical Trials: Medical Device and Drug Development
Clinical Trials - Medical Device & Drug Development: Information Session
- 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
- UC Irvine Extension 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
Graduates from UC Irvine Extension’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.
- 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