Clinical Research and Product Development - M.S.

Graduate Coordinator: Dr. James Lyon

The UNCW Clinical Research Program offers a Master of Science degree in Clinical Research and Product Development. This is not a laboratory-based degree. The Program provides a didactic and rigorous curriculum that prepares graduates from mid-to upper-level roles in the biopharmaceutical clinical research industry. Graduates work in biopharmaceutical companies, contract research organizations, clinical research investigator sites, academic medical centers, government agencies, niche service providers, and other associated organizations in research teams formed to conduct the clinical trials necessary to move new drugs, biologics, and biomedical devices through the regulatory process to reach regulatory approval and post-marketing studies required for drug safety and used for label/market expansion. An understanding of the four phases of clinical research involving human subjects is fundamental to all coursework. The importance of laws, regulations, guidance, and Good Clinical Practice is emphasized throughout the curriculum. Business aspects of the industry, particularly project management and market competition, are also covered. The Clinical Research Management Concentration is offered entirely online providing students with the flexibility to pursue the degree from any location with internet access.

Admission Requirements

Students who are taking, or have taken graduate work elsewhere must be in good standing at the last institution to be eligible to take graduate work at UNCW.

Admission requirements include:

A minimum of a bachelor’s degree, preferably in a life science, health care discipline or mathematics/statistics, from a regionally accredited college or university completed before graduate study begins.
Strong academic record with an undergraduate GPA of 3.0 or better.
Experience working in the biopharmaceutical or related industry of at least two years is preferred
Applicants must have access to a computer capable of supporting electronic mail, a web browser, a word processing program and multi-media presentations. In addition, applicants must be proficient in the use of these computer applications.
Application and supplemental documents must be submitted by the published deadline

Supplemental documents required for admission:

An application for graduate admission
Official transcripts of all college work (graduate and undergraduate)
Current resume or curriculum vitae
Brief essay addressing the student’s career goals and associated interest in the degree program (not to exceed 2 pages, double spaced)
Three recommendations (at least one from a current or former employer)

Degree Requirements (36 total credit hours)

A total of 36 credit hours is required and must include 12 credit hours of core courses, 21 credit hours of additional coursework, and 3 credit hours for the capstone project.

Degree Options

Required Core Courses (12 credit hours)

CLR 501 - Clinical Research Monitoring and Ethics Credit Hours: 3 *
CLR 510 - Advanced Scientific Writing & Interpreting Medical Literature Credit Hours: 3 *
CLR 520 - Regulatory Affairs & Quality Management Credit Hours: 3 *
CLR 550 - Clinical Research Trial Design & Data Management Credit Hours: 3 *

Additional Coursework (21 credit hours)

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 Transfer and Intellectual Property Management Credit Hours: 3
CLR 555 - Innovative Drug Product Development Credit Hours: 3

Required Capstone Project (3 credit hours)

The M.S. in Clinical Research and Product Development requires a capstone project, which is completed while enrolled in the CLR 597 , a 3-credit capstone requirement taken over two or more semesters. Students may enroll in the capstone course after completing at least 27 credit hours including all of the required core courses. Students requiring additional time to complete their project may enroll in continuous enrollment in subsequent semester.

Additional Information

Students must maintain a 3.0 GPA while enrolled in the M.S. in Biopharmaceutical Clinical Research degree. Six semester hours of graduate level transferred credit from a regionally accredited institution may be accepted upon approval.

The NC residency for tuition purposes requirement follows those requirements as outlined in the North Carolina State Residence Classification Manual.

Program Learning Outcomes for Clinical Research and Product Development

In addition to the core learning outcomes, upon completion of the M.S. curriculum the new graduate will be able to:

Identify key components in the forecasting and managing of resources necessary for the execution of clinical trial programs including budget, timelines, and deliverables
Discuss product development strategies in the context of domestic, international, and foreign laws and regulations; guidance documents; good clinical practice; market factors/competition; and health care policy
Describe primary differences in the regulatory approval processes for the US and the European Union, particularly in the context of health care policy, reimbursement, research ethics, and data privacy
List sources for regulatory guidance for the evaluation of safety and efficacy of new biopharmaceutical and device projects in the areas of clinical development, product manufacturing, and clinical compliance
Evaluate critical domestic and global regulatory and health care issues that challenge and influence biopharmaceutical product development
Effectively assess and manage ethical clinical trial programs and biopharmaceutical development projects
Forecast the resources necessary for developing and managing biopharmaceutical clinical research grants and trials as required and regulated by global regulatory agencies
Discuss the objectives and rationale for late phase studies involving epidemiology, pharmacovigilance/drug safety concerns, pharmacoeconomics, psychometric/patient-reported

Program Learning Outcomes for the Core Component

Upon completion of the M.S. curriculum, the new graduate will be able to:

Describe the processes by which biopharmaceutical and device industry move products from pre-clinical development to regulatory approval and post-marketing studies with emphasis on key regulations, ethics, and good clinical practice
Discuss approaches to ensuring high quality clinical study data across the design and implementation process, including protocol/case report form design, monitoring, data management, statistical analyses, and reporting
Write professionally and scientifically
Search, summarize, and synthesize the scientific literature; communicate findings effectively