Bridging sponsor-site operations through reciprocal on-site training of CRAs and CRCs: Impact on workflow knowledge...

Opportunities for face-to-face interaction between sponsor-side clinical research associates (CRAs) and site-side clinical research coordinators (CRCs) have decreased with remote and risk-based monitoring, potentially impeding communication and mutual understanding - key determinants of team functioning. Accordingly, we implemented a reciprocal on-site training to enhance CRA-CRC mutual understanding and evaluated its impact.

Seventeen sponsor staff, including 11 CRAs, joined an 8-hour hospital tour with CRC-guided process simulations and discussion; conversely, 14 hospital staff, including 11 CRCs, attended a 4-hour sponsor-office visit with system demonstrations and discussion. Self-assessed understanding of counterpart workflows and impressions of the counterpart group were rated pre- and post-training on 5-point Likert scales. Free-text feedback underwent text-mining analysis. Behavioral change was surveyed 6 months later.

CRAs improved on all 9 understanding items (e.g. "flow of daily medical practice:" median score 2.0 vs. 4.0, pre- and post-training, respectively, p < 0.0001); CRCs improved on 4 of 5. Positive impressions increased and negative impressions decreased in both groups (e.g. "bright atmosphere:" median 3.0 vs. 5.0 for CRAs, p = 0.0002; 3.0 vs. 5.0 for CRCs, p = 0.0044). Text-mining revealed the specific content participants learned, which included keywords reflecting this training's objective of enhancing mutual understanding. At 6 months, 70% of CRAs and 88% of CRCs reported changes in their work behavior.

A brief, reciprocal, on-site training improved CRA-CRC mutual understanding and perceptions, with sustained self-reported behavioral changes in work practices. From a team science perspective, such practical training may strengthen sponsor-site communication and collaboration.