北卡莱罗纳大学威明顿分校

This major offers students the opportunity to gain specialized education, training, and experience in the exciting field of clinical research. Clinical Research is the process by which new therapies (medications, biological agents, and devices) are tested in clinical studies prior to approval. Clinical Research also includes the study of products after approval once they are on the market, particularly for rare or unexpected adverse events. Students in the Clinical Research program gain a broad-based understanding of the science, regulatory, and business aspects of developing new therapies to treat illness and improve quality of life.

Our program is situated in a vibrant clinical research industry here in Wilmington, providing ample opportunities for students to gain hands on experience through internships. FuseCR (The Center for Clinical Research Workforce Development) was recently developed to fuse the ties between academia and industry, which benefits our students in their readiness for the workplace.

Upon completion, graduates are prepared to participate in the science and business of developing health care products, such as drugs, biologics, and biomedical devices with emphasis on pre-approval human clinical trials and post-marketing safety studies. Our alumina is employed in a variety of settings such as pharmaceutical, biotechnology, and patient device companies; contract research organizations (CROs); clinical settings; and government agencies. This is an online distance education program that requires 2 semesters of internship at a clinical research organization.

Program 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.