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

At the time of graduation students should be able to:

Demonstrate a foundational understanding of clinical research methodologies described in study protocols with emphasis on study design, operational aspects, and regulatory compliance.
Integrate knowledge and skills gained in the basic sciences to the planning, implementation, and evaluation of clinical research.
Apply and explain scientific and regulatory concepts related to the development, design, and analysis of clinical studies for biopharmaceutical and medical device product development.
Evaluate ethical issues, including the protection of human subjects and the evaluation of safety in the conduct of clinical studies, in the context of underlying regulations and guidelines.
Explain processes and rationale for clinical study operations in the context of Good Clinical Practice and other relevant guidelines and regulations (e.g., study management, monitoring, safety management, handling of investigative products, data management)
Describe the collection, flow, and management of data through a clinical study and the role of statistics and informatics.
Interpret statistical results from the published studies in the peer reviewed literature and clinical study reports.
Demonstrate leadership, professionalism, oral and written communication, and team work skills in clinical research.

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.