Clinical Research Management

Stephen 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.

Program Requirements

Each student is responsible for the completion of the requirements for the Clinical Research Management program according to the procedures that follow. Each item must be completed in the sequence and time period indicated. Forms are subject to revision at any time and should be obtained from the GSBS Forms and Guidelines website.

1. The admissions committee will review all applicants for acceptance into the MS program in Clinical Research Management. A student must have a bachelor’s degree and must meet the general admission requirements as described in the catalog in effect at the time of application.
2. By the end of the spring semester, the student will be assigned a major professor and an advisory committee consisting of the mentor and two other graduate faculty members. The names of these individuals will be filed on the designation of advisory committee form with the Graduate School of Biomedical Sciences (GSBS) Office of Admissions and Services. A degree plan must also be filed with GSBS’s Office of Admissions and Services at this time.
3. Students must be in good academic standing prior to be allowed to start their internship at a site (cumulative GPA 3.0). Exceptions to this rule can only be granted by the dean or his designee.
4. During the summer and fall semesters of year two, the student will enroll in Internship Practicum (BMSC 5697; 9 SCH). The student will complete a six-month unpaid internship at a site approved by the graduate school. The student should not expect to receive a stipend or other monetary compensation for the internship. The student is responsible for transportation to and from the site. During this time, the student will learn how to perform the duties expected of particular clinical research positions in clinical research centers such as a hospital or clinic, pharmaceutical or medical device company, a clinical research organization or site management organization.
5. A formal research proposal describing how the practicum is to be spent must be approved by the advisory committee and submitted to the graduate school 4-6 weeks after starting the internship..
6. At the end of the Internship Practicum (BMSC 5697), students will present their work as both oral and written reports. The oral presentation will be open to the public and will then be followed by a private defense with the advisory committee. The student must submit a first draft of his/her internship practicum report and internship daily journal to the major professor prior to the public seminar for review. The major professor must approve the internship practicum report prior to the student submitting it to advisory committee members. The final written report should be given to the committee no later than two (2) weeks before the formal defense. Students should coordinate the reservation of a seminar room with the Graduate School office no later than one (1) month prior to their defense. At this time, the committee will either approve or disapprove the work of the practicum and the report. If not approved, the student may have a chance to revise the report or repeat the practicum one time at the discretion of the committee. The major professor, together with the other members of the committee, will assign a letter grade to the final semester of practicum. The report must be submitted in accordance with the instructions for completing graduation requirements within the deadlines for graduation published in the GSBS Academic Calendar. A more detailed description of the internship practicum and report requirements may be found in the Internship Practicum Guidelines available on the GSBS Graduation website.
7. It is strongly suggested that the student and major professor, as well as the major professor and the on-site mentor, communicate on a regular basis to review the student’s progress during the practicum. 

Internship Practicum (BMSC 5697)

The Internship Practicum provides a hands-on training experience for the graduate student whose master’s degree will be in the specialized discipline of Clinical Research Management. The program director will identify approved, on-sight and off-campus internship opportunities in north Texas and will work to place students at suitable sites. The internship may take place either on-campus or at an approved off-campus site in the Dallas-Fort Worth-Denton Metroplex and, in some cases, at a site in other parts of the state or country. UNT Health Science Center (UNTHSC) does not offer any remuneration to the student when he/she is enrolled in BMSC 5697 and the student should not expect to be paid as an intern.  Students will be expected to provide for their own transportation and housing needs during the internship experience. The student is expected to keep a daily journal during this experience. Drug testing and a criminal background check are required before starting an internship. At the end of the practicum, the student will write a final practicum report detailing the activities of the internship. The student’s advisory committee must approve this report together with the daily journal. The student must make a formal presentation to the advisory committee and defend the work at this time. A copy of the report must be submitted within the appropriate deadlines for graduation as published in the GSBS Academic Calendar.

Support

In general, master’s students do not qualify for graduate assistantships. They are, however, eligible to apply for the Elena and Thomas Yorio Scholarship for First-Year Students and the Rachel Dauphin Memorial Scholarship (continuing students).