HHD 410: Clinical Research Practice Partners with CTSI to advance workforce development
Clinical researchers are a crucial component to medical, health, and behavioral research, as they serve the integral purpose of interacting with the research participants. Clinical researchers conduct clinical trials, recruit and screen participants, maintain patient care, administer trial drugs and placebos, and submit findings upon completion of the trial. Without these highly-skilled mediators, clinical and human subjects research would be severely limited.
Historically, clinical research coordinators have been nurses. However, the field is losing nurses to early retirement and general attrition. Fortunately, not every clinical researcher needs to have experience as a registered nurse. Moreover, many behavioral health studies might be better suited to clinical researchers who are trained in other fields, such as psychology or sociology.
HHD 410: Clinical Research (CR) and Practice is helping the field diversify the knowledge of the CR workforce, and providing a fast track for undergraduates to enter the CR field upon graduation without additional training.
HHD 410: Clinical Research Practice began at Penn State University Greater Allegheny (PSU GA). Through a partnership with Allegheny Health Network (AHN) and initial funding through Penn State Clinical and Translational Science Institute (CTSI), Kyle Bird, director of the AHN Research Institute, created the course, and Kristal Tucker, associate professor of biology, served as the campus liaison. This initial course offered health science students a unique opportunity to get hands-on experience in the clinical environment before graduation. In addition, the course served to recruit a more diverse workforce to the Pittsburgh-based hospital system.
Now, an expanded version of this course offers the same benefits as the initial course but broadens the geographical reach to students across four campuses: Greater Allegheny, New Kensington, University Park, and the Harrisburg campuses. In addition, the course has evolved into a full program that prepares the new generation of clinical researchers, thanks in large part to the continued collaboration with Penn State CTSI, support from the College of Medicine to advance its strategic plan, the leadership from Andrea Stevens, PhD, Undergraduate Clinical Research Training Program Coordinator and assistant professor in biology at PSU GA,and Kevin Gardner, RN, BSN, CCRC, Director of the Clinical Trials Office at Penn State College of Medicine (COM). Stevens had to re-evaluate the course and revise the curriculum to address undergrads in the life sciences. Gardner serves as the intern coordinator at Penn State COM. Together, Stevens and Gardner work closely to help the interns navigate the process. They also provide structure to the internship that allows for continued education and professional development over the summer.
How are students being recruited? Stevens has assigned a campus liaison at each of the four campuses, and five seats are available per campus. The liaison promotes the program in undergrad research labs and in 2+2 science majors. Acceptance into the course is highly competitive and requires a short application and an essay that asks applicants to detail their interest in working in clinical research.
In addition to giving students from multiple Penn State campuses access to this course, the new program expands the scope of what is offered to students. The program now includes a fall semester course that targets science-driven students, typically juniors whose majors are bio-medicine or bio-behavioral health, or those who are preparing for medical school or physician assistant school. Following completion of the course, students are afforded additional training and professional development. The program concludes with opportunities for internship placement supported through Penn State COM, as well as potential summer internships through AHN.
With the benefit of industry and field guest lecturers, students get access to the skills and tools they need to be effective clinical research coordinators, who are responsible for interacting with study participants, or associates, who generally monitor and validate data. Students learn the hands-on skills of research applied to human health and disease as well as the professional skills needed to conduct regulatory oversight. Course materials cover human subjects’ protection, research administration, good clinical practice, data management, and finance and budgeting of trials.
After the students complete the course, they are eligible to apply for internships and jobs at clinical research organizations.
The internship allows students to be fully immersed in the clinical research process, with a focus on understanding the importance of consent as an ongoing process and effective communication with participants.
The internship program provides students and participating organizations with a set structure that includes milestones. Students have the option to attend a summer poster symposium to present their research. The symposium offers students a social networking opportunity as well as a space to practice speaking in public.
Penn State CTSI has been instrumental in the growth of this program. In addition to being the main funding source behind the initial course development by Bird and Tucker, the CTSI provided the community partnerships necessary to build a greater collaborative network when Stevens took over. The program runs under the workforce development service area within the CTSI in close collaboration with James A. Pawelczyk, Ph.D and Kevin Harter, MBA. Nicole Tarr, MPH, is instrumental in providing community outreach support and in establishing community partnerships, such as with AHN and Penn State COM. As a member of the CTSI, Stevens coordinates all efforts and direct all aspects of the program seamlessly.
This year, 97% of the students who enrolled in HHD 410 were placed in internships with Penn State COM, AHN, and Clinical Research Strategies being the three main sites.
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