Clinical research coordinators (CRCs) play a key role in supporting the translational research enterprise, with responsibilities encompassing tasks related to the design, implementation, and evaluation of clinical research trials. While the literature explores CRC competencies, job satisfaction, and retention, little attention has been given to the role of the PI working with Human Resources (HR) in the CRC hiring and onboarding processes. We investigated the priorities, decision-making processes, and satisfaction levels of principal investigators (PIs) and hiring managers in CRC hiring.

An online survey consisting of open-ended and fixed-choice questions to gather information on desired CRC qualifications and competencies, factors influencing hiring decisions, and overall satisfaction with selected candidates was administered. The survey utilized a Task/Competency Checklist developed from job descriptions and the literature. Respondents were asked to rank the importance of factors such as CRC skill set, years of experience, educational background, and budget constraints.

Results indicated that the skill set of the applicant was the most frequently cited factor influencing the hiring decision, followed by years of experience. Education and budget constraints were of lesser importance. Most respondents reported a satisfaction rating of 50% or greater with their new hires, although some participants expressed challenges related to institutional training requirements, the performance of entry-level CRCs, and the qualifications of experienced candidates.

The hiring cycle involves HR-PI collaboration for a clear job description, effective onboarding processes, and accessible professional development opportunities to enhance PI and employee satisfaction and CRC retention.

Purposeful training and ongoing career support are necessary to meet the evolving and expanding roles of clinical research professionals (CRP). To address the training and employment needs of clinical research coordinators (CRCs), one of the largest sectors of the CRP workforce, we designed, developed, and implemented an online career navigation system, eMPACTTM (eMpowering Purposeful Advancement of Careers and Training).

A design-based research method was employed as an overarching approach that frames iterative design, development, and implementation of educational interventions. The five major phases of this project – conceptualization, task analysis for measurement development, algorithms development, algorithms validation, and system evaluation – presented specific goals and relevant methods.

The results reported how the eMPACTTM system was conceptualized, developed, and validated. The system allowed CRCs to navigate tailored training and job opportunities by completing their task competencies and career goals. The data sets could, in turn, support employees’ and training coordinators’ informed decisions about organizational training needs and recruitment. The early dissemination results showed steady growth in registered CRCs and diversity in users’ ethnicity and job levels.

The eMPACTTM service showed the possibility of supporting CRCs’ individual career advancement and organizational workforce enhancement and diversity. Long-term research is needed to evaluate its impact on CRC workforce development, explore key factors influencing workforce sustainability, and expand eMPACTTM service to other CRP sectors.

Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers’ research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.

Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.

Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29–205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2–9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (P = 0.01), but not with the total number of studies, geographical location, or institution type.

The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.

There is a clear need to educate and train the clinical research workforce to conduct scientifically sound clinical research. Meeting this need requires the creation of tools to assess both an individual’s preparedness to function efficiently in the clinical research enterprise and tools to evaluate the quality and effectiveness of programs that are designed to educate and train clinical research professionals. Here we report the development and validation of a competency self-assessment entitled the Competency Index for Clinical Research Professionals, version II (CICRP-II).

CICRP-II was developed using data collected from clinical research coordinators (CRCs) participating in the “Development, Implementation and Assessment of Novel Training In Domain-Based Competencies” (DIAMOND) project at four clinical and translational science award (CTSA) hubs and partnering institutions.

An exploratory factor analysis (EFA) identified a two-factor structure: the first factor measures self-reported competence to perform Routine clinical research functions (e.g., good clinical practice regulations (GCPs)), while the second factor measures competence to perform Advanced clinical functions (e.g., global regulatory affairs). We demonstrate the between groups validity by comparing CRCs working in different research settings.

The excellent psychometric properties of CICRP-II and its ability to distinguish between experienced CRCs at research-intensive CTSA hubs and CRCs working in less-intensive community-based sites coupled with the simplicity of alternative methods for scoring respondents make it a valuable tool for gauging an individual’s perceived preparedness to function in the role of CRC as well as an equally valuable tool to evaluate the value and effectiveness of clinical research education and training programs.

This study identified underlying career orientation types of clinical research coordinators (CRCs) using cluster analysis. Select career (satisfaction, engagement, and planning) and competency-related (perceived competence) information was used to identify four distinct career orientation types.

A web-based survey was administered to CRCs employed in one of four research institutions affiliated with a National Institutes of Health-funded Clinical and Translational Research Award (CTSA) in the southeastern USA. Each respondent completed a survey containing questions about personal background, individual attributes, perceived professional competence, and career orientation.

The first CRC type (35.2%) possessed a positive, knowledge-seeking orientation, characterized by high career-related scores but a conservative assessment of perceived competence. The second CRC type (18.6%) represented an optimistic and confident career orientation reflected in moderate to high scores on each of the four identifying factors. The third CRC type (27.6%) reflected an inconsistent career orientation highlighted by lowered perceived competence. The final CRC type (18.6%) reflected a disengaged orientation characterized by negative responses to all career and competence factors.

Understanding the career orientation of CRCs can be helpful to institutional administrators and clinical investigators as they seek to support the professional development of CRCs through tailored training efforts or work-related supports. Knowledge of career orientation may also inform individual CRCs as they manage their personal career paths by assessing current levels of functioning, career-related strengths or weaknesses, and training needs.