Education and training remain key elements in the development and professionalization of the clinical research workforce. Certain institutions are advancing standardization by reconfiguring their clinical research job descriptions and workforce to be competency-based, modeled on the core competencies for clinical research professionals established by the Joint Task Force for Clinical Trial Competency (JTFCTC; see Sidebar 1).{1,2}
Two research-intensive academic medical centers (AMCs) are seeing benefits from competency-based job classifications.
Duke: A pioneer in adopting the JTFCTC framework as part of workforce model
“While Duke is home to the world’s largest academic research organization, the Duke Clinical Research Institute (DCRI), Duke also houses a large site-based clinical research portfolio,” says Denise Snyder, MS, RD, Associate Dean for Clinical Research, Duke University School of Medicine. “Duke University’s Schools of Medicine and Nursing currently employ more than 900 clinical research professionals, with around 200 new hires per year. During fiscal year 2023, Duke had more than 2,200 active studies involving more than 24,000 Duke patients.”
A pioneer in adopting of the JTFCTC framework as part of a workforce model, Duke began developing a competency-based pathway in 2014, establishing buy-in from leadership while “Duke-ifying” the JTFCTC competencies. As Snyder explains, the next step, in 2016, was to map the workforce and use the Title Picker tool developed in Research Electronic Data Capture (REDCap){3} to systematize job postings aligned with competencies.
“Title Picker compares a description of job responsibilities with standardized job descriptions, supporting consistent job classifications and internal functional alignment, and providing a better understanding of the workforce,” states Snyder. This tool led to simplification of more than 80 job titles into 12 standardized, well-defined job classifications,{4} which form the basis of career ladders including tiered positions that enable employee advancement within a particular role. Training is also aligned with competencies.
Snyder concludes, “More still needs to happen, including better definitions of roles, responsibilities, and accountability. We are already putting additional resources into a workforce engagement and resilience program. In 2022, this included creation of ‘new hire’ cohorts across Duke, providing opportunities for recent hires in all disciplines to network and learn from one another. We are also working on new pathways to enter clinical research roles, such as apprenticeships through the Duke University School of Medicine and helping develop a specialized ‘early college high school’ as part of the Durham, N.C., public school system. Here, students will simultaneously earn both a high school diploma and an associate degree or workforce credential for aligned healthcare occupations. These projects will be funded by a recently announced Bloomberg grant.”{5}
UAB: Advancing workforce standardization and professionalization
“As a public research institution, The University of Alabama at Birmingham (UAB) has underway hundreds of clinical trials across multiple specialties at any given time,”{6} says Mark Marchant, Executive Director of the Clinical Trials Administrative Office at UAB. “We needed a way to standardize our clinical research staff hiring process. Our institution has collaborated closely with Duke, a private university, for the past five years, benefiting from lessons learned during its earlier implementation of competency-based job classifications. Since we began hiring using these classifications in 2020, UAB’s clinical research staffing has increased by around 100%.”
UAB breaks its Clinical Research Career Ladder into five tracks or types of roles—administration, coordinator, data, nurse coordinator, and regulatory, explains Marchant. “Based on education, applicable experience, and certification, individuals are placed at five levels—level I, level II, level III, manager, and director,” he notes. “We decided to stop requiring two years of experience for entry-level clinical research roles, taking the mindset that talented people can advance in this field with appropriate training and mentoring.”
Lessons Learned from Implementing Competency-Based Job Classifications at Two AMCs
Join Denise and Mark at ACRP 2024 [May 3–6; Anaheim, Calif.], as they look at the implementation of the Joint Task Force for Clinical Trial Competency (JTFCTC) Framework for competency-based job positions at two research-intensive academic medical centers View complete schedule.
At present, UAB has 724 clinical research staff (100 administrators, 386 coordinators, 78 data coordinators, 119 nurse coordinators, and 41 regulatory coordinators). These staff fall within a total of 21 job titles. “Improving the consistency of job titles and descriptions helps clarify what each individual does, and facilitates movement both within and between departments,” notes Marchant. “Our clinical research staff receive targeted communication and educational offerings from UAB,” states Marchant. “A possible next step would be to require certification for certain promotions.”
Marchant concludes, “We are now sharing our experiences with other academic medical centers in hopes of making their lives a little easier as they work to achieve standardization and professionalization of the clinical research workforce, and to improve awareness of clinical research as a ‘hidden jewel’ of a profession that offers a fulfilling career path.”
Sidebar 1: About the JTFCTC Core Competency Framework
The Joint Task Force for Clinical Trial Competency (JTFCTC){7} Core Competency Framework for Clinical Research Professionals aims to standardize competency expectations for the clinical research workforce by defining the knowledge, skills, and attitudes needed to conduct safe, ethical, and high-quality clinical trials. JTFCTC comprises an international team of investigators, educators, and other stakeholders, including ACRP. The framework focuses on eight core competency domains:{8}
- Scientific concepts and research design
- Ethical and participant safety considerations
- Investigational products development and regulation
- Clinical study operations (Good Clinical Practices)
- Study and site management
- Data management and informatics
- Leadership and professionalism
- Communication and teamwork
References
- https://mrctcenter.org/clinical-trial-competency/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198073/
- https://pubmed.ncbi.nlm.nih.gov/18929686/
- https://eric.ed.gov/?id=EJ1162072
- https://giving.duke.edu/gift-announcement/bloomberg-grant-funds-innovative-partnership-for-early-college-high-school-in-durham/
- https://www.uabmedicine.org/specialties/clinical-trials/
- https://mrctcenter.org/clinical-trial-competency/
- https://acrpnet.org/competency-domains-clinical-research-professionals/
