Clinical Research Administration, M.S.

*** This program is pending approval by the Connecticut Office of Higher Education.  We anticipate the program will be available beginning with the fall 2025 term. ***

*** Updated 05/07/2025: this program has been approved by the Connecticut Office of Higher Education. ***

STEM Designation: This program is STEM (science, technology, engineering, and math)-designated by the Department of Homeland Security. For more information, please see https://www.newhaven.edu/admissions/stem-designated-programs.php

Because this is a STEM designated degree program (51.2006), F1 students are eligible for a STEM OPT extension.

The program in Clinical Research Administration is a two-year, graduate level academic program requiring 39 credit hours. Required core courses and program elective courses include the drug, biologic, vaccine, and device development process, good clinical practice (GCP), federal regulations and guidelines (the United States and international), clinical research protocol development, implementation, study start-up, management and close-out, study monitoring, research ethics, regulatory compliance, risk management. and a culminating project. Students have the chance to participate in a credit-bearing, hands-on preceptorship experience at a clinical site conducting clinical research, a contract research organization, a biotechnology corporation or a pharmaceutical firm which sponsors and monitors clinical trials. Students that successfully complete the 20-credit core curriculum including a clinical preceptorship are awarded a post-baccalaureate Certificate of Clinical Competency. 

Graduates are prepared for leadership positions in the pharmaceutical and biotechnology industries, government agencies, medical institutions, academic institutions and hospitals. Within these fields, graduates are qualified to work as clinical investigators, clinical research associates (in-house or remote), clinical research coordinators, research data coordinators/managers, project support/project managers, safety specialists, regulatory managers, and many other positions.

Program Outcomes

At the end of the program, the student will be able to:

1. Explain the scientific basis for research design and analysis.
2. Apply principles of bioethics and scientific integrity to the protection of human subjects.
3. Manage studies for clinical research and new medical product development in compliance with federal regulations and principles of good clinical practice.
4. Demonstrate leadership, cultural and linguistic competence, and effective oral and written communication as a member of the clinical research team.