Guest Column | August 30, 2018

The Time Is Now To Professionalize The Clinical Trial Workforce

By Jim Kremidas, executive director, Association of Clinical Research Professionals (ACRP)

The Time Is Now To Professionalize The Clinical Trial Workforce

Donna was the office manager for a trucking company. Terri worked at the reception desk of a contract research organization (CRO) straight out of high school. Tom lost his job teaching history at a community college after a round of layoffs. Jessica earned her living at a local hair salon.

What do each of these people have in common? Like thousands of others, they stumbled into becoming clinical research coordinators (CRCs). Some turned out to be terrific hires. Some were mediocre performers. A few were personnel disasters.

When you stop and think about it, the lack of standards and core competencies in the clinical trial industry is stunning. Mechanics must get licenses. Masseuses must earn certifications. Jessica the hairdresser was required to pass performance tests before she was allowed to set up shop at her chair.

Joining the clinical trial workforce? It’s as easy as performing well enough in an interview to get hired. In many cases, entry-level applicants have no demonstrable expertise in clinical trials or in any aspect of healthcare delivery. Hiring managers are rolling the dice and hoping for the best when they interview a small pool of candidates for a growing number of jobs. Ultimately, the Human Resources unit doesn’t have much hard evidence to inform a smart decision.

It’s a sad state of affairs, and one that translates into erratic clinical trial quality, a failure to leverage the latest technologies and best practices, and fuel for the fire driving a staggeringly high employee turnover rate. Searching for new hires is an expensive and time-consuming affair. Discovering someone does not have the aptitude for the job three months after they were hired is not good for anyone involved.

It’s an untenable situation. And it must stop.

We all understand that clinical trials are an integral component of advancing new drugs and devices. They help protect the public from flawed products, even as they help connect patients with new drugs and devices that improve, and in some instances save, the lives of millions. In many cases, clinical trials are further benefiting the public by being used as a new means to provide high-quality healthcare. For underserved communities in particular, this can be a godsend.

Today, I’m encouraged by a renewed, focused energy in the clinical trial industry to develop and embrace new entrant standards to help better match the right skills with the right jobs. The Association of Clinical Research Professionals (ACRP) is part of a broad array of industry players, including sponsors, CROs, and other stakeholders, to bring thought leaders together to create standardized core competencies and design career maps to attract — and retain — the best and the brightest into the clinical trial fold.

We’re hoping this initiative to develop competency standards for CRCs will transform the clinical trial landscape by professionalizing the workforce. One goal is showing those on the front lines a new respect by helping them learn everything they need in order to thrive and maximize their talents.

As one clinical trial leader at an academic medical center told me recently, “One of the things that I’ve really liked with ACRP is that they’re looking at sub-specialty designations like project management and other spinoffs of certifications, so that it does allow for you to grow a career based on what you like to do, and where you think your skills are well matched, and where you feel like you can [contribute the most] to seeing the research be successful.”

The initiative is driven by ACRP’s Workforce Innovation Steering Committee (WISC), whose membership includes representatives from a broad group of private and public stakeholders, including Association of Clinical Research Organizations (ACRO), Amgen Inc., Bioclinica, Greater Gift Initiative, Medix, Medtronic, National Institutes of Health, Pfizer, PPD, Roche, and the U.S. Department of Veterans Affairs Office of Research and Development.

ACRP created the WISC to provide oversight for needed workforce standards activities intended to improve quality and respond to changes occurring in the clinical research enterprise. The WISC has been active since 2017, holding meetings and developing position papers laying the groundwork for the adoption of much-needed defined core competencies, career paths, and entry-level hiring standards to lift clinical trials to the next level.

We’re looking to build as big a tent as possible as we search for the best ways to craft and spark a new mind-set in our important industry. Together, we can reduce turnover rates, boost CRC and CRA morale, and enjoy more effective, less expensive clinical trials that will bring the highest quality drugs and devices to a waiting public.

Isn’t that what we’re here for?

I’d love to hear your thoughts and insights. Are you willing to help your industry benefit from your real-world experience? Please post your comments below or contact me at

About The Author:

Jim Kremidas is the executive director for ACRP, a not-for-profit association that represents the clinical research enterprise. Previously, he provided consulting services including support for investigator sites, academic institutions, sponsors, and suppliers. He was SVP of patient recruitment at two large CROs for over six years, during which he and his teams were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company, including in leadership roles in clinical trial patient recruitment and retention, outsourcing of clinical development projects, selection and establishment of relationships with direct-to-consumer and professional advertising agencies, and implementation of standardized processes for the development of marketing materials. He is on the advisory board of the Center for Information and Study on Clinical Research Participation (CISCRP) and is also a volunteer for the Clinical Trials Transformation Initiative (CTTI).