Clinical Research Operations, Post-Baccalaureate Certificate

Program Objectives:

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

1. Explain scientific concepts related to the design and analysis of clinical trials.
2. Explain the care of patients, aspects of human subject protection, and safety in the conduct of a clinical trial.
3. Describe how investigational products are developed and regulated.
4. Describe the study management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.
5. Describe operations at the site level to run a study (financial and personnel aspects).
6. 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.
7. Demonstrate the principles and practice of leadership and professionalism in clinical research.
8. 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:

1. An application for graduate admission.
2. Official transcripts of all prior university or college coursework (undergraduate and graduate).
3. Three letters of recommendations describing the individual’s potential to complete the program (at least one from a current or former employer).
4. Current professional resume or curriculum vitae.
5. 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:

1. No transfer credit from another institution will be counted toward the completion of the certificate program.
2. 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. The course options selected are subject to approval by the program coordinator.

Students are required to take in the first semester:

• CLR 505 - Fundamentals of Clinical Research Credit Hours: 3

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  After successful completion of CLR 505, students are required to take 4 core courses and 1 additional course listed below.