Clinical Research Operations, Post-Baccalaureate Certificate

Graduate Coordinator: Mr. Jared Kerr

The Post-Baccalaureate 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 an asynchronous distance education extension program.

Program Objectives:

Upon completing the Post-Baccalaureate Certificate in Clinical Research Operations program, participants will be able to:

Explain scientific concepts related to the design and analysis of clinical trials.
Explain the care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial.
Describe how investigational products are developed and regulated.
Describe the study management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.
Describe operations at the site level to run a study (financial and personnel aspects).
Describe how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, correction and the concept of a locked database.
Demonstrate the principles and practice of leadership and professionalism in clinical research.
Describe elements of communication within the site and between the site and sponsor, CRO, and regulators, including the teamwork skills necessary for conducting a clinical trial.

Admission Requirements:

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.

Track 1:

Students with less than 2 years of experience (who do not hold an undergraduate degree in clinical research) are required to take:

CLR 505 - Getting Started in Clinical Research Credit Hours: 3
CLR 506 - Clinical Research Operations and Regulations Credit Hours: 3
After successful completion of CLR 505 and CLR 506 , students are required to take the 3 core courses and 1 of the additional courses listed below.

Track 2:

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.

Core Courses:

CLR 501 - Clinical Research Monitoring and Ethics Credit Hours: 3
CLR 520 - Regulatory Affairs & Quality Management Credit Hours: 3
CLR 550 - Clinical Research Trial Design & Data Management Credit Hours: 3

Additional Courses:

CLR 510 - Advanced Scientific Writing & Interpreting Medical Literature Credit Hours: 3
CLR 512 - Pharmacotherapeutics for Clinical Research and Product Development Credit Hours: 3
CLR 515 - Epidemiology and Safety Credit Hours: 3
CLR 525 - Current Issues in Global Regulatory Development and Management Credit Hours: 3
CLR 530 - Project Management in Clinical Research Credit Hours: 3
CLR 540 - Post-marketing Studies Credit Hours: 3
CLR 545 - Biopharmaceutical Technology Management Credit Hours: 3
CLR 555 - Innovative Drug Product Development Credit Hours: 3
Successful completion of the certificate program requires an overall cumulative GPA of 3.0 for all courses. Completed certificate courses may be applied to the Master of Science in Clinical Research and Product Development, in accordance with the GPA guidelines (3.0 or greater) and other admission requirements of the Graduate School, and contingent upon acceptance into the master’s degree program.