Clinical Research, B.S.

The UNCW Clinical Research Program prepares individuals for participation in the science and business of developing drugs, biologics, and biomedical devices with emphasis on pre-approval human clinical trials and post-marketing safety studies. Most graduates work for pharmaceutical and biotechnology companies, contract research organizations, clinical research service providers, or clinical sites enrolling clinical trial subjects. This is an online distance education program that requires 2 semesters of internship at a clinical research organization.

The Clinical Research Program is not a nursing or laboratory-based program.

Student Learning Outcomes

Upon completion of the BS in Clinical Research curriculum, the graduate 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.
Explain the study management (adverse event identification and reporting, post-market surveillance, and pharmacovigilance), and handling of investigational product.
Explain the operations at the site level to run a study (financial and personnel aspects).
Demonstrate how data are acquired and managed during a clinical trial, including source data, data entry, queries, quality control, and 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.

Requirements for a Major in Clinical Research for the B.S. Degree:

Collateral Courses (28 hrs)

Core Courses (52 hrs):

Select one of the following as a Core Course elective (3-4 hrs):

Total Degree Requirements: 83-84 hours

Additional Information:

A “C” (2.00) or better is required in each required CLR core course to progress. A cumulative grade point average of 2.00 or better is required for graduation.

A “C” (2.0) or better is required in all required non-CLR courses to apply to/progress in the program.

All required CLR 300 level courses must be taken prior to enrollment in internship (CLR 496 ).

Many of the required courses are sequential, have prerequisites, and may be offered only once a year; therefore, it is imperative that students consult with the academic advisor and follow the prescribed program of study. Students are also expected to complete the university studies requirements during the freshman and sophomore years because of the rigor and concentration of lab courses and the internship in the major. The recommended 15-17 semester hour course load each semester is necessary to complete the program in four academic years. In addition to the university studies and required prerequisite courses, elective credits are also included in the 124 hours required for graduation. To qualify for the Bachelor of Science in Clinical Research, 25% of the total semester hours must be taken in residence at UNCW.