Principal Investigators Should Invest in CRCs to Boost Overall Trial Performance

john rowell

John P. Rowell, BSN, MSN, CCRC, CEO of Bio Research Consulting

Principal investigators (PIs) looking for a proven way to improve their clinical trial performance and experience need look no further than investing in the entry-level clinical research coordinators (CRCs) who are in some ways the foundations for the ultimate success of trials, says John P. Rowell, BSN, MSN, CCRC, CEO of Bio Research Consulting.

A well-trained CRC can help a PI to be more successful in a number of ways, Rowell notes. For example, a strong CRC can ensure the PI properly handles a myriad of Good Clinical Practice (GCP) issues, compliance requirements, recruitment and management of patients, and knowing what records need to be maintained and how they need to be distributed, he says.

“A good coordinator helps make for a good PI,” Rowell adds. CRCs who have a handle on record-keeping policies, procedures, and reporting expectations are key to advancing success on the clinical trial operations side, he says. In addition to being good at laying out timelines, a skilled CRC can help a PI know what documents and information to ask for throughout the trial process.

Rowell also advises fledgling CRCs and their clinical research associate contacts on the sponsor side to learn how to be better communicators. “They need to learn how to communicate with PIs, institutional review boards, and [each other],” he says.

Being a solid communicator begins with a willingness to ask questions, Rowell says. “Don’t be afraid” to seek information or get to the bottom of something, he notes. He also stresses the importance of cultivating skill in written communication, especially when it comes to e-mails.

“A good CRC will learn how to write e-mails designed to get the answers they need” in a given situation, Rowell says.

Author: Michael Causey