Is the clinical research associate (CRA) workforce on the cusp of a big shift? The short answer is yes, leading experts predict.
“The pathways to electronically sourcing study data (eSource) and reducing or even eliminating redundant data are going to create an exciting future for CRAs,” says Craig Lipset, an advisor at multiple startups and technology companies and former head of clinical innovation at Pfizer. “We will finally see the shift from [CRAs being] ‘data reviewers’ to true clinical partners with the site [and] helping [with tasks from quality assurance to] study conduct,” he adds.
Lipset is excited about the future he sees. “I believe this will create a lift for CRAs who love the clinical and scientific aspects of the role, and will help CRAs to operate at the highest levels of the role,” he says.
ACRP Southeast Regional Confernece
Lipset will keynote the first-ever ACRP regional conference, October 3-4, 2019 in Durham, NC. Earn 12 ACRP contact hours, connect with your community and get up to date on key clinical research issues, including technology’s impact, workforce development, CRO/Site Relations, regulatory developments, inspection preparation and more.
Not surprisingly, new technologies in and of themselves are expected to have a big impact on the humans toiling in the workforce, too. “CRAs will benefit from more opportunities to monitor remotely with eSource and source data in electronic medical records and eRegulatory options,” says Susan Donahue, CCRC, ACRP-PM, director of clinical trial operations at Javara Research. She believes CRAs will also “leverage more scheduled Skype or video conferences to conduct monitoring visits.”
Ironically, those technological demands will force the workforce to rethink how it functions on an interpersonal level, Donahue believes. “We’ll need to be more consistent with clinical research training across all stakeholders, including soft skill training, and promoting consistent knowledge of the protocol and indication for CRAs conducting pre-study, site initiation, and monitoring visits,” she adds.
“I think the role of the CRA is going to become much more rigorous in the next five to 10 years,” says Joy Jurnack, RN CCRC, FACRP, senior director for site engagement with Slope.io, Inc. “They are going to need to come to the table with the same competencies and baseline knowledge of clinical research coordinators and nurses,” she adds.
Author: Michael Causey
