Clinical Trial Leaders Challenge Experience Requirements Hampering Workforce Development

The organizations leading clinical studies that help bring new treatments and therapies to market – including vaccines – are facing an expanding global workforce shortage. According to industry leaders convened by the Association of Clinical Research Professionals (ACRP), the issue is a self-inflicted wound.

“The increasing number of investigational medicines entering clinical development has prompted a surge in demand for qualified researchers,” says Merck’s Jennifer Sheller, Associate Vice President, Global Clinical Trial Operations. “We need to work together as an industry to address this acute workforce challenge.”

Sheller co-directed an industry-wide forum this April at ACRP’s annual conference in Orlando to discuss the barriers to global workforce development and to explore potential bridges to building a diverse, research-ready workforce.

Members of ACRP’s Partners Advancing the Clinical Research Workforce – an unprecedented consortium formed to identify disruptive ways to address the growing workforce shortage – say two key challenges are threatening development of this critical workforce.

First, in a white paper published today by ACRP, they acknowledge that there is a lack of awareness of clinical research as a profession – even after the publicity it gained during COVID-19 vaccine development.

But the consortium highlighted a second, incontrovertible barrier: the default prerequisite for a specific number of years of experience – very frequently two years – in entry-level job descriptions.

“We are leaving out some of the most innovative minds with this arbitrary minimum requirement,” says Jeanne Hecht, Founder and CEO of JTH Consulting, LLC and a former executive at large contract research organizations (CROs). “Our industry must evolve and re-examine some of its archaic practices.”

Members of ACRP’s consortium include leaders from pharmaceutical sponsors, CROs, investigator sites, support industries, and academic institutions.

“We’re seeing a lot of well-qualified candidates not being considered,” says Sharleen Traynor, Fieldwork Coordinator/Instructor with Durham Tech’s Clinical Trials Research Associate Program. “It’s a rigid, exclusionary system that bars potentially promising people, especially those with fewer financial resources. As in many other fields, communities of color tend to be impacted most.”

The consortium’s white paper – Bridges to Barriers: Addressing the Urgent Need for a Diverse, Research-Ready Workforce Within the Clinical Research Profession – captures key takeaways from its April forum.

  • The workforce must be more diversified to support the sustainability, quality, and reliability of clinical research. Education is needed about how staff diversity builds trust with under-represented groups whose participation in clinical research is imperative for understanding potential safety and efficacy differences in real-world populations.
  • Industry leaders must address both the lack of awareness about clinical research as a profession and the multi-year experience stipulation. Earlier this year ACRP launched its Ready, Set, Clinical Research™ toolkit for recruiters, employers, and other stakeholders to use in introducing candidates to the clinical research profession.
  • The clinical research enterprise needs an authoritative framework that defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality research.

“The clinical research industry is in a global workforce crisis which can only be solved by an immense collaborative effort,” says Susan Landis, Executive Director of ACRP. “We need to harness all organizations to address this urgent issue in a way that we have never seen before in our industry.”