Skip Navigation

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. Source: Economic Modeling Specialists Intl.

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 Medical Devices (3.00 Units)
EECS X445.2
to be scheduled 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 Online to be scheduled
BIO SCI X450
Fundamentals of Clinical Trials (3.00 Units)
BIO SCI X450
to be scheduled   Online  
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
to be scheduled      

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 X413.45
Clinical Trials Project Management (3.00 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
×

Academic Calendar

Event Spring 2020 Summer 2020 Fall 2020 Winter 2021
Registration Begins Jan 24 Apr 24 Jul 17 Oct 23
Courses Begin* (week of) Mar 30 Jun 22 Sep 21 Jan 4
Courses End* (week of) Jun 8 Sep 7 Dec 14 Mar 15
Parking Permits Expire Jun 30 Sep 30 Dec 31 Mar 31
Administrative Holidays Mar 27, May 25 Jul 3, Sep 7 Nov 11, Nov 26-27, Dec 24-25, Dec 31 Jan 1, Jan 18, Feb 15

*Actual dates may vary by program.

×

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

Frequently Asked Questions

  • How much does the program cost?
  • Fees for each course vary from $450 - $725 based on unit value. There is also a one-time candidacy declaration fee of $125, to be paid after your second class. Therefore, the entire program costs $5,050. Note that you pay for each class as you enroll, as opposed to the entire tuition sum at once. Please keep in mind that this cost does not include textbooks, which some of our instructors do require. Textbook information for specific courses can be found on our website on the enrollment page. Students may purchase textbooks from the vendor of their choice. Prices are subject to change without notice.
  • How long will it take me to complete the entire program?
  • It depends on how many courses you can take at once. A certificate is awarded upon completion of 16 total units, the 11 required courses and minimum of 5 elective credit units each with a letter grade of “C” or better. On average, you can complete the program in 12-18 months. Most students who work full time take one or two classes per quarter, depending on their work schedules and other obligations. You can take as many courses as you wish simultaneously, but we strongly recommend starting with one or two to ensure you have the necessary time to devote to the course(s).
  • If I am interested in taking courses from other Life Sciences Certificate Programs can these programs share electives?
  • Yes, you can share up to six units or two Electives courses between the Medical Device Development Certificate Program and the Regulatory Affairs and Compliance Certificate Program.
  • Do I have to apply and be accepted before I start?
  • No. This is an open-enrollment program, and you will not have to provide transcripts or prove prerequisites before you begin.
  • Where can I find the course schedule? Do I have to take the classes in order?
  • The course schedule can be found here. You may take the classes in any order that you like. We recommend, starting with the required courses as they build the foundation of the program and then moving onto the elective courses.
  • Can I complete the entire program online?
  • Yes, this is a fully online program.
  • I've never taken an online class. How does it work? Is it self-paced?
  • No, the classes are not self-paced. Our online classes take place in an asynchronous online environment, meaning there will not be a day of the week or time of day that you will need to be online. You can log in when you have time to do so. However, the courses are structured week-to-week, from Monday to Sunday, and you are expected to log in multiple times during the week to keep up with class discussions and assignments. Some instructors may hold optional synchronous sessions which happen in real time. These sessions will be recorded and posted in the course for all students to access.
  • I am an international student / I am located overseas – am I able to enroll?
  • Yes. As an open-enrollment program, international students are welcome in the program. Please note that if English is not your native language, enrollment in this program assumes that you have a working proficiency in English to allow you to engage in high-level academic discourse without any additional language coaching. If you are interested in taking the program fully online, you may enroll in courses via the Continuing Education website at your convenience and on a quarter by quarter basis. You are not required to have a student visa while taking online courses from your home county.

    If you wish to apply for an F-1 student visa to study in person at UC Irvine Division of Continuing Education (DCE), you must formally apply to UC Irvine DCE's International Programs and request an I-20. Please keep in mind that not all evening certificate programs are available to F-1 student visa holders based on the availability of classes that meet on campus. We cannot issue an I-20 for fully online programs. Please visit International Programs or email uciesl@uci.edu for more information.
  • Do you offer job placement at the end of the program?
  • No. While UCI DCE does not offer placement services, our certificate certainly puts you in a good position to find employment. Additionally, the networking to be done in the class can also be invaluable. Our advisors, instructors, and a good number of our students, are current professionals in the industry, and are an excellent resource for hiring trends and opportunities.
  • Is UC Irvine Division of Continuing Education an accredited institution?
  • Yes. We are affiliated with the University of California system of schools, and are accredited through WASC. DCE programs are all approved by the respective school within UCI. For more information, please visit UCI Accreditation.
  • What is the “declaration of candidacy”? When do I have to complete it?
  • The declaration of candidacy can be thought of as declaring your major for the certificate program. This lets our student services know that you intend to complete the entire program, and puts you on track for the certificate when you have completed all requirements. We strongly recommend that you complete the declaration of candidacy and pay the applicable fee before enrolling into your third class.
  • Are there scholarships or financial aid available for this program?
  • o Since UCI DCE is the continuing education unit of the university, we do not offer/accept any federal financial aid or scholarships. If you take courses through us, you may apply directly to private lenders like Wells Fargo for funding. It is recommended that you begin the loan application process early as UCI DCE does not enroll students in courses until payment is received, and applying for a loan does not reserve a space in the course. For more information, please visit Student Loan Programs. If you have any questions regarding student loans, please contact Student Services at 949-824-5414. For more financial information, please go to Financial Information.
  • I can't find the answer to my question.
  • If you have any additional questions, please feel free to contact Kadie Heck at kheck1@uci.edu or (949) 824-7648.

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.