Winning Hearts and Souls

Clinical Researcher—December 2018 (Volume 32, Issue 10)


Jim Kremidas


Clinical research is a team sport. If the people conducting the trial aren’t working as a seamless team, you’re looking at a trial with such potential problems as adverse events, missed enrollment targets, and other inefficiencies threatening quality and extending already costly bench-to-bedside timelines.

I was excited to join the ACRP team just over three years ago for several reasons, including the fact that our primary membership encompasses study coordinators, principal investigators, and site monitors, among professionals in many other roles. So, when you get right down to the execution of the clinical trial, ACRP members are the people on the front lines ensuring the safety of the patients, pulling and entering the data, and monitoring the documentation, among so many other critical tasks day in and day out.

Yes, we’re a good team. Now it’s time to take it to the next level. That means taking a hard look at how we do things and being open to the idea of change. It’s not always an easy transition.

Making Change Stick

Throughout my earlier work with Eli Lilly, Quintiles (now IQVIA), and other sponsors and contract research organizations, when we tried to drive change in management, we usually took it from a top-down perspective—getting senior executives engaged, trying to drive the change initiative down through the organization, and making changes for the better “stick.” But what I found early on was that you can’t do it just from the top down, especially in the medical field, because it’s like herding cats. If you really want to effect change, you’ve got to win people’s hearts and souls—getting those at the grassroots level engaged and believing in the principles of what you’re trying to change.

Having seen so much of the research and development cycle from “the other side,” the opportunity to come to an organization that represents the people who are conducting the protocols was exciting. The entire ACRP team—our membership and staff—are working together to change how people work at the protocol level, so that we can make the changes that need to occur in the industry. This includes new training opportunities, new certifications, and new standards to help define the roles and expectations for every member of the trial team.

Past, Present, and Future

Looking back on the past few years, I’m excited about all that we’ve achieved together and the “State of the Union” ACRP finds itself in as 2018 comes to a close. But you know what? I’m even more excited about what we’re going to achieve in 2019.

As always, thank you for your hard work and commitment delivering the safest, efficient and most effective clinical trials possible.

Jim Kremidas ( is Executive Director of ACRP.