The authors would like to acknowledge funding for this initiative from Duke's CTSA grant UL1TR001117, as well as contribution and leadership from the following individuals: Mark Stacy, Billy Newton, David Smithwick, Andrea Doughty, Mary Smith, Angie Cain, Leigh Burgess, Rebecca Moen, and the countless research professionals that contributed to this work.
The role of the clinical research professional has evolved substantially in the past 20 years due in large part to the ever-changing field of clinical research. The regulatory requirements have grown and responsibilities multiply to keep pace with the shifting research landscape (Johnson, 2013). This results in additional burden for investigators and study teams. Changes in the past 20 years have created the new environment in which clinical research is conducted. The emergence of the electronic medical record has required research staff to learn new documentation practices and policies. The executive order signed by President Bill Clinton in 2000 allowed for payment of standard of care research, however, this National Coverage Determination added layers of complexity around payments. The proliferation of international trials introduced additional complexity around site and study management, an understanding of laws, and tedious communication. HIPAA requires staff to have a deeper understanding of privacy concerns and ethics in research. From FY 2003 to 2013, the National Institutes of Health (NIH) effectively lost 22% of its capacity to fund research, creating greater pressure for clinician scientists to secure external support to pay for their research (National Academies of Sciences, Engineering & Medicine, 2016).
As the work in clinical research has come to embody far more than the pursuit of improved patient care, this has meant that staff supporting the research are asked to go farther than simply recruiting participants into studies and ensuring study visits and interventions occur as intended. While job responsibilities and roles may have changed rapidly, the job descriptions and classifications held by individuals performing the tasks have not (Stevens & Daemen, 2015). In addition, training demands and resources for development have soared (Speicher et al., 2012). To address the increased responsibilities and complexities of work, Duke University School of Medicine leadership agreed that an overhaul of job descriptions for clinical research professionals was needed. Job descriptions related to clinical research at the institution had not been updated in more than fifty years. However, a simple "update" of the jobs was not enough; instead, a deep dive was pursued with an intensive review from a focused workgroup representative of many stakeholder groups, and engagement across the institution for departments, centers, institutes, faculty, staff and administrators who may potentially be impacted. The workgroup reviewed literature, researched options and existing models in the field with clinical research professional organizations and participated in CTSA activities before choosing a competency-based model (Sonstein et al., 2014). This is consistent with other fields, where competency models are adopted to ensure readiness of the workforce, and assess skills needed for appropriate conduct of a specific job (O'Neil, 2014).
There is a need to professionalize the research professional workforce in order to continue to produce high quality clinical research. This means that those involved in clinical research need to ensure that the roles we are asking staff to fill are 1) well-articulated, 2) competency-based, 3) appropriately matched to experience and educational level, and 4) have descriptions that are updated frequently to keep up with the shifting landscape. In an attempt to do just that, Duke University undertook a large effort to revise job classifications for research professionals. Below, we describe the steps taken towards professionalizing the workforce in this large academic medical center.
Observations and Methods
Formation of a working group
Human Resources departments within institutions cannot take on a transformation like this on their own as they may not have the subject matter expertise. Therefore, for the purposes of refining job classifications at Duke, the multidisciplinary Clinical Research Professionals Working Group (CRPWG) was formed. This group included those who have grown up in the field of clinical research for over twenty years, representatives from Human Resources (corporate, school, and department levels), and administrators key to the clinical research enterprise. The group was relatively stable, with approximately 10 participants who have remained very engaged in the process over a three-year period. The group convened every 2-3 weeks, and tackled assignments in between meetings. Process and implementation was driven by a core group in the institution's central clinical research support office (known as the Duke Office of Clinical Research; (Snyder et al., 2016)).
Importantly, the workgroup was committed to transparency and engagement within the research community. This was facilitated by the creation of a wiki page, which was visible to the School of Medicine, and was updated roughly once a week, with draft documents available for review. Workgroup members frequently presented to the research community in order to address concerns, (see engagement below). We requested feedback in a variety of venues, and incorporated suggested edits to the plan when appropriate. The group ensured that throughout the process, the research community had a voice and an opportunity to participate in shaping the long-term vision.
Finally, our group connected frequently with contacts at other institutions working on similar initiatives. Members of our committee took part in meetings with other Clinical and Translational Science Award consortium members about the supplement "Enhancing Clinical Research Professionals' Training and Qualifications," which aims to improve the safety, efficiency, and quality of clinical trials by establishing standardized educational competencies and training across the CTSA Consortium. Our committee members who worked with this group assisted with the refinement of competencies in several domain areas.
Key to the success of the initiative is frequent and true engagement with a variety of stakeholders. The CRPWG engaged groups in three general realms: Administrative leaders, faculty, and the research community. The message threaded through conversations with each group is that the long-term investment in...