A Day in the Life of a hybrid Clinical Research Associate and Clinical Trial Manager

Clinical positions are the highest profile roles at every start-up medical device company. For Clinical employees this means being comfortable with high visibility, pressure, and change - all while delivering results in an environment where timelines are tight, stakes are high, and success depends on cross-functional collaboration.

At a large device company, the study CRAs are the monitor, the educator, and the troubleshooter, while the CTMs are the point person, balancing short-term execution with long-term strategy. At a start-up, you get to do it all- here's a sample what that might look like in practice.

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• 8:00 AM: Review site performance, enrollment, and open queries - while also scanning emails - urgent ones may come from a surgeon with a protocol question, or a site coordinator with EDC questions. Then reviewing and emailing the agenda for the next day's meeting- it should be out to attendees 24 hours ahead to give them time to review

• 9:00 AM: Lead a study team call with quality, regulatory, and other stakeholders -a big part of oversight is being in communication with leadership to review study issues, progress, roadblocks, etc.

• 11:00 AM: Draft a monitoring report, send out the preliminary action items

• 1:00 PM: Review essential documentation for a new site, update the activation checklist, and review their qualification report - the SIV is less than a week away and the goal is to activate them immediately after the SIV is complete.

• 3:00 PM: Meet with the executive team to present risk mitigation strategies for slow enrolling sites. Write up the notes from all the meetings of the day and send them out for review and finalization.

• 5:00 PM: Update timelines, re-prioritize resources, and prep the next day’s goals - a start-up, priorities shift daily.

As you know, both the CRA and CTM roles by themselves are critical - not only ensuring regulatory compliance and patient safety but also shaping the clinical strategy and execution from the ground up. Doing both of these well requires organization, attention to detail, experience, and just a little bit of obsession