A new competency-based job framework was implemented for clinical research professionals at a large, clinical research-intensive academic medical center. This study evaluates the rates of turnover before and after implementation of the new framework. Turnover in this workforce (as with most) is costly; it contributes to wasted dollars and lost productivity since these are highly specialized positions requiring extensive training, regardless of experience in the field.

Trends in employee turnover for 3 years prior to and after the implementation of competency-based job framework for clinical research positions were studied using human resources data. Employee demographics, turnover rates, and comparisons to national statistics are summarized.

Employee turnover within the clinical research professional jobs has decreased from 23% to 16%, a 45% reduction, since the implementation of competency-based job framework.

The new jobs and career ladders, both of which are centered on a competency-based framework, have decreased the overall turnover rate in this employee population. Since little is known about the rates of turnover in clinical research, especially in the academic medical setting, the results of this analysis can provide important insights to other academic medical centers on both employee turnover rate in general and the potential impact of implementing large-scale competency-based job changes.

Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).

SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.

Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.

The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.