Oct 02, 2023
Graduate Coordinator: Dr. James Lyon
The Post-Baccalaureate Professional Certificate in Clinical Research Operations is designed for individuals with a bachelor’s degree who are interested in 1) entering the clinical research field or 2) obtaining additional education to facilitate a move into a different area within the clinical research field including career progression. The program focuses on foundational knowledge and skills necessary to understand the structure, function, and operations of biopharmaceutical companies, clinical research organizations, clinical study sites, academic medical centers, and other organizations involved in biopharmaceutical clinical trials. The program requires 18 credit hours for completion and is provided completely online as asynchronous distance education extension program.
Certificate Program Objectives:
Upon completing the Clinical Research Operations Certificate program, participants will be able to:
- Explain the marketing approval process (pre-clinical to phase IV) for new drugs, biologics, and devices from operational, scientific, and regulatory perspectives.
- Compare and contrast differences in the drug approval process in the U.S. to other countries and regions.
- Distinguish each phase of product development in terms of overall objections, applicable study designs, populations studied, types of clinical endpoints, and connection to information included in the approved product labeling.
- Select appropriate regulations and guidelines, used in the U.S. and abroad, to guide specific activities related to new biopharmaceutical and device product development from the site, sponsor, and subject perspectives.
- Examine and critique approaches for ensuring high quality clinical trial data related to protocol and case report form design, site activities, monitoring, data management, statistical analyses, safety reporting, and development of regulatory reports.
- Construct a model for forecasting and managing the resources necessary for the execution of clinical trial programs including budget, timelines, and deliverables.
The minimum admission standards for candidates for the Clinical Research Operations Certificate program:
A bachelor’s degree preferably in a life science, health care discipline, or mathematics/statistics from a regionally accredited university or college in the U.S. (or its equivalent from a foreign institution based on a four-year program) with a minimum GPA of 2.5.
To apply for admission to the graduate Certificate in Clinical Research Operations program, the candidate must submit the following:
- An application for graduate admission.
- Official transcripts of all prior university or college coursework (undergraduate and graduate).
- Three letters of recommendations describing the individual’s potential to complete the program (at least one from a current or former employer).
- Current professional resume or curriculum vitae.
- Application and supplemental documents must be submitted by the published deadline.
These admissions requirements apply only to the graduate certificate program in Clinical Research Operations. Students interested in combining the certificate program with a master’s degree will have to meet all admission criteria for that degree.
Policies Governing Certificate Admission Criteria and Subsequent Admission to Graduate Degree Programs
The certificate admission criteria and policies governing the relation of certificates to graduate degree programs include the following:
- No transfer credit from another institution will be counted toward the completion of the certificate program.
- A certificate graduate student may enroll on either a part-time or a full-time basis.
Certificate Requirements (18 credit hours)
The program requires a minimum of 18 credit hours. Students admitted to the program are placed into 1 of 2 tracks based on their level of clinical research experience. The track and course options selected are subject to approval by the program coordinator.
Students with less than 2 years of experience (who do not hold an undergraduate degree in clinical research) are required to take:
Students with approximately 2 or more years of experience or an undergraduate degree in clinical research are required to take the 3 core courses and 3 of the additional courses listed below.