PROSPER Formed to Serve the Clinical Research Community, Strengthen Research Programs
Running a clinical research study is an enormous undertaking. Principal investigators are faced with designing and overseeing the study, establishing funding, safeguarding clinical research participants, collecting data, reporting adverse drug effects, and publishing results, often while managing other research projects and attending to clinical responsibilities.
Investigators often turn to the expertise of clinical research coordinators (CRCs) to address the complexities of the day-to-day management of clinical studies. Investigators rely on CRCs to help them with all aspects of clinical research studies, often delegating responsibility for several components of a study to the CRC. Adding to the challenge, CRCs are often assigned to help with multiple studies.
To support the individuals who serve in this complex and demanding role, members of the CHOP Research community have developed an organization to serve as a resource for all clinical research staff in the CHOP Research community. Called PROSPER, based on its intention to be a PROfessional Society for PEdiatric Clinical Research, the society offers ongoing support for new and seasoned research personnel and serves as an avenue for clinical research interactions. Since its launch in 2008, PROSPER has gathered more than 250 members and has assembled multiple committees that work on shared education, communication, and planning goals.
CHOP Research CRCs include clinical research staff representing a diverse range of departments, divisions, and centers. PROSPER creates a community where all CRCs can interact and gain support in common areas of interest and concern. In one such effort toward this goal, PROSPER has built a robust Web site, available on the CHOP Research intranet, that serves as a centralized information source of what it takes to conduct research at CHOP.
Information provided on the PROSPER site includes education on federal regulations governing clinical research, the human subjects protections overseen by the Institutional Review Board, research billing requirements and implications, and the Hospital’s clinical management systems. Augmenting PROSPER’s educational efforts are the events the society holds, which have a dual purpose of education and networking. At PROSPER events, new and experienced CRCs can learn from each other and make connections for shadowing and mentoring opportunities in which knowledge can be shared to enhance the CRC experience.
PROSPER is also addressing the expanded scope of the CRC’s role, recognized nationally as an issue that challenges research organizations. Traditionally, CRCs were assigned to oversee the clinical management of patients enrolled in a clinical study and ensure human subject protection. Today, the expectations of a CRC’s role are broader and include many sophisticated tasks requiring expertise in regulatory compliance, research administration, study sample and drug processing, marketing, and financial management.
PROSPER is working to create a standardized job description for CRCs and establish new job categories within the CHOP Research infrastructure to relieve CRCs from tasks that detract from their ability to carry out core responsibilities. PROSPER plans to use the restructured job categories to develop a career ladder for the CRC pool in an effort to retain experienced, talented employees who facilitate and expedite the research process.
In addition to serving the CRC community, the resources PROSPER provides benefit the Research Institute as a whole. CRCs are in the unique position of navigating the clinical research process for both investigators and research participants, with great implications for the Institute’s research program and reputation. By improving the information provided to CRCs, PROSPER is increasing the general understanding of complex issues clinical researchers face, which in turn, is improving the clinical research CRCs manage.
PROSPER’s work toward a new employment structure for CRCs will also have a beneficial effect on research studies. CRCs with clear career paths and advancement opportunities will continue to work within the CHOP Research Institute, enhancing and continuing CHOP Research’s cadre of experienced and dedicated CRC professionals.
With leadership from Lisa Speicher, PhD, Denise DePaul, RN, and an active steering committee, PROSPER is positioned to continue toward its goal of supporting the research community by focusing on continued outreach and education efforts. In the coming year, PROSPER will coordinate with other CHOP Research organizations and with a similar society at the University of Pennsylvania to enhance the educational resources available to CRCs and other members of the clinical research community at CHOP Research.