Don’t get burned by relying on tenure when making new hires, Jill Matzat, RN, BSN, CCRA, and owner of Medical Research Management and CRA Solutions, Inc. told attendees of the ACRP 2018 Conference in Gaylord Harbor, Md.
“I tell sponsors it’s not about 1-2 years of experience, it’s about a skillset,” she said during her session, “Smart Monitoring: Is My Monitoring Adequate?” Good monitoring requires “critical thinking” and must be about more than source documentation, Matzat added.
Time serviced “does not always translate into adequate monitoring,” she emphasized, citing a quick example of a monitor she hired with six years of experience. Matzat brought the monitor onboard largely based on tenure and did not put the applicant through rigorous testing. The problem? They didn’t have adequate knowledge and talent and their job performance was disastrous. Ultimately Matzat had to fire her.
What does she look for when hiring? “Competency training, GCP knowledge” and good old-fashioned organization and time-management smarts. It’s important for a clinical research associate (CRA) to have a real-world sense of how long a given task will take and set their priorities accordingly, she said.
Matzat is a big fan of assessing an applicant’s skill set at the outset. She also championed a training system to make it easier for entry level contract research associates (CRAs) to have a clear path, eschewing arbitrary tenure obstacles.
Matzat offered some observations regarding why most monitoring deficienies occur, including:
- Incorrect version of consent form.
- No documentation of the consent process. It’s a common mistake to only note that the document is present. That can of error can be the result of Good Documentation Practices (GDP).
- Incomplete protocol procedures. “Matching data in the CRF but not reviewing for compliance,” she said.
- Product not used as required per usage instructions.
- No Principal Investigator (PI) oversight or securing a signature with dates. That can happen when the monitor is “only matching from the CRF to the source,” Matzat explained.
She also urged more mentoring for clinical trial professionals. “See one, do one” mentoring offers little room for feedback or professionals growth, she said.
Instead, learn from past non-compliance events. Maintain a repository of issues and resolutions. Finally, “hold monitoring round table discussions” to make the mentoring a valuable two-way experience.
Author: Michael Causey