Clinical Trials: Medical Device and Drug Development
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.
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
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
Certified Clinical Research Professional (CCRP)
Individuals seeking this designation from The Society of Clinical Research Associates (SOCRA), and who hold an associate 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.
Eligibility and Requirements
Apply to become a candidate for the program: A Declaration of Candidacy is required to establish candidacy in this program. Complete the application and pay the application and candidacy fee of $125 (non-refundable). Learn more about the benefits of becoming a candidate. Candidacy is not required to enroll into individual course in a program.
A candidate in the program is awarded a certificate upon the successful completion of 11 required units and a minimum of 5 elective credit units totaling 16 units, each with a letter grade of “C” or better. All requirements must be completed within five (5) years after the student enrolls in their first course. To receive the Certified Digital Certificate after completing all the program requirements, students must submit the Request for Certificate to initiate the certificate audit process. Students not pursuing the certificate are welcome to take as many individual courses as they wish.
Discount
- Orange County Regulatory Affairs (OCRA) members save 10% on tuition. Email membership@ocra-online.org.
- San Diego Regulatory Affairs Network (SDRAN) members save 10% on tuition. Email membership@sdran.org.
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Have Questions?
Talk to an enrollment coach
Call: (949) 824-5414
Monday - Friday, 9am - 4pm (Pacific)
Course Schedule
Course schedules are subject to change. Individual courses may be taken without enrolling in the full program.
Frequently Asked Questions
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.
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