Stephen O. Mathew, PhD, Graduate Advisor
Center for Bio Health (CBH) building, Room 417
Phone: 817-735-5407
E-mail: Stephen.Mathew@unthsc.edu
Clinical research involves testing and determining the safety and efficacy of new unapproved products, including pharmaceuticals, devices, and biologics in human subjects. Clinical trials in humans (volunteers and patients) are required before 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 clinical research professionals. 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 provides a strong foundation upon which to build or advance 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, or captsone project, in clinical studies and use this experience to write the internship practicum, or capstone project, report pursuant to receiving the Master of Science (MS) degree. The average time to complete the degree is eighteen months. A comprehensive list of course requirements is available online.
Clinical Research Management Program
An applicant to the Clinical Research Management program may apply to either the online option or the cohort option. Each year students in the cohort option will enter in the summer semester and students in the online option will enter in summer, fall, or spring semesters. All students complete a six-month practicum experience. A comprehensive list of course requirements is available online.
Cohort Option
The cohort (on-campus) option is designed for the student that works best in a team setting alongside other students with daily faculty interaction. Cohort students will participate in didactic lectures interacting in real time with faculty and other students. The average time to complete the program is eighteen months with full-time enrollment.
Online Track Option
The online option is designed for the student balancing work and family responsibilities with enrollment. The MS degree is completed online except for an internship practicum/capstone project experience. In addition to the rigorous curriculum, students will have online access to advising. With three starting points each year, students in this program can begin classes at the time most convenient for them. The average time to complete the program is eighteen months with full-time enrollment.
Campus resources are available from Financial Aid to the Library, including Career Services and the Center for Academic Performance, without traveling to our physical location.
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 to shorten the product 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, and clinical research trainer. 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 (e.g., private, clinic, or 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.