Stephen O. Mathew, PhD, Graduate Advisor
Research and Education Building, Room 202F
Phone: 817-735-5407
E-mail: Stephen.Mathew@unthsc.edu
Clinical research involves the testing and determination of safety and efficacy of new unapproved products, including pharmaceuticals, devices and biologics in human subjects. Clinical trials in humans (volunteers and patients) are required prior to marketing approval, by regulatory authorities such as the U.S. Food and Drug Administration (FDA). The law that governs clinical research is spelled out in Chapter 21 of the Code of Federal Regulations (CFR). In addition to requiring and legislating clinical trials, regulatory authorities define the standards by which clinical trials are to be conducted. These standards are known as Good Clinical Practices (GCPs).
In depth knowledge of the CFR and GCP guidelines as well as international guidelines specifically as they relate to protection of human rights, prevention and detection of fraud and the use of sound scientific principles, is a fundamental requirement for a clinical research professional. These individuals are key personnel involved in the conduct of clinical trials, which in turn are pivotal in getting new products approved and on the market.
The master’s program in Clinical Research Management will provide a strong foundation upon which to build a career. The rigorous curriculum focuses on providing students a broad-based view of the biomedical sciences, as well as in depth knowledge of regulatory requirements (code of federal regulations, good clinical practices), ethical issues, and both the medical writing and administrative skills necessary to conduct clinical research. As part of the program, all students will complete an internship practicum in clinical studies and use this experience to write the internship practicum report pursuant to receiving the Master of Science (MS) degree. The average time to complete the degree is eighteen months. Students are only admitted in the summer semester. A comprehensive list of course requirements is available online.
Opportunities for Graduates in Clinical Research Management
Well-trained clinical research professionals are in high demand. The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development.
Clinical research professionals can hold a multitude of positions either in industry, at the investigational site, or in the clinical research service profession either at a contract research organization (CRO) or a site management organization (SMO). Job titles may include, but are not restricted to, clinical research associate, clinical research scientist, clinical research coordinator, medical writer, clinical trial auditor, clinical trial monitor, product safety specialist, clinical research trainer, etc. Industry (sponsor) and service professions (CRO, SMO) usually provide technical and managerial career paths and ample growth opportunities.
Typically a clinical research coordinator who has been involved with the implementation and coordination of a clinical trial at a research site (private, clinic, hospital), will advance his/her career by switching to either industry or one of the service professions. Others make the reverse switch because they prefer the interactions with the patients, or they may want to travel less than what is typically required from a clinical trial monitor. Turnover in all these industries and positions is relatively high because of the growing variety of choices clinical research professionals have, especially after they have accumulated a number of years of experience.