Clinical Research Management
Patricia Gwirtz, Ph.D., Graduate Advisor
Research and Education -103
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. An IRB/Regulatory Affairs Track will provide additional training to those individuals whose career goal is in regulatory affairs and/or management of IRB committees. As part of the program, all students will complete an internship practicum in clinical studies and use this experience to write the thesis pursuant to receiving the Master of Science degree. The average time to complete the degree is eighteen months. Students are only admitted in the summer semester.
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.
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 can be obtained from the GSBS Forms and Guidelines site.
- 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.
- 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 GSBS Office of Admissions and Services. A degree plan must also be filed with the GSBS Office of Admissions and Services at this time.
- 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.
- During the summer of year two, the student will enroll in Internship Practicum (BMSC 5697). The student will complete a six-month unpaid internship at a site previously approved by the graduate school. 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.
- 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.
- At the end of the practicum, the student must submit a report and internship daily notebook to the mentor for his/her approval. The advisory committee will meet with the student at this time and review both the notebook and written report. The student will present his/her work as both an oral and written report. The oral presentation will be open to the public and will then be followed by a private meeting with the advisory committee. The written report should be given to the committee two weeks before the formal meeting. 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 mentor, 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 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.
- 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.