By Susan P. Landis, executive director, ACRP
How many clinical research professionals does it take to deliver on today’s drug development pipeline? By some measures, there may be 33,631 to 56,700 clinical research coordinators (CRCs) working at clinical trial sites in the U.S. at present.1,2,3,4 All are tackling such vital tasks as helping sponsors with study initiations at the site, recruiting and communicating with study volunteers, handling the informed consent process, managing patient visit schedules, responding to sponsors’ and institutional review boards’ requests for information, collecting study data, and assisting the principal investigator in many other ways. That figure doesn’t include other roles integral to the clinical research profession, such as study monitors, data managers, and regulatory compliance specialists. The importance of so many patient-facing and behind-the-scenes duties all wrapped up into one CRC position cannot be underestimated. According to one source, demand for CRCs is expected to rise, with an estimated 57,200 new jobs filled by 2029, representing an annual increase of 36.1% over the next few years.5
The projected growth of the clinical research industry demands that the workforce keep pace with the workload — and it must be diverse and research-ready. What’s at stake? Nothing more than the risk of delaying approvals of new treatments for patients who need them.
I had the privilege to be part of a thought-provoking forum earlier this year sponsored by the Association of Clinical Research Professionals (ACRP) and its Partners Advancing the Clinical Research Workforce consortium. It brought together thought leaders from across the clinical research spectrum to dissect the reasons for this challenging and concerning situation and to consider how best to turn barriers into bridges.
First, we need to understand the obstacles preventing growth of the clinical workforce. The problem begins with the lack of recognition of the clinical research profession as just that — a profession acknowledged and tracked by the Bureau of Labor of Statistics, as is, for example, the nursing profession. With this type of recognition, the industry might have a repository of data that would help provide an evidence-based understanding of the industry’s needs. There’s also a lack of recognition in industry publications of the breadth and depth of contributions from clinical research study teams beyond principal investigators. A report from earlier this year, the National Academy’s 2030 Transformation of the Clinical Research Enterprise, barely mentions the clinical research industry workforce. It’s not surprising, therefore, that there is a lack of awareness of the clinical research profession as a career option.
Experts at the ACRP forum unanimously highlighted a second incontrovertible barrier: the default prerequisite for a specific number of years of experience — very frequently two years — in too many entry-level job descriptions. Unintentionally, industry stakeholders have created a catch-22 situation: even if significant efforts are made to raise awareness of the profession — and the fulfilling careers it offers — many of those who demonstrate interest and potential will end up blocked by this very first, unnecessary hurdle.
The urgent need for a fundamental “system fix” is further highlighted by the impact on those already in the profession and the organizations that employ them. When entry restrictions are too tight, there is a costly tug-of-war over existing employees, with employers offering increasingly competitive packages and trying to outdo one another in the race to secure human resources. It is a shortsighted view of the challenge, and the result has been an alarming rate of churn in the profession, in part from counterproductive job poaching, with serious adverse effects on organizational productivity, operational continuity, team building, and morale. Clinical research sites are reportedly experiencing the greatest drain on talent, as it is well acknowledged that these providers function as the industry’s training ground for entry-level employees.
With full acknowledgment of my bias toward advocating for clinical research professionals, here are some simple — and not so simple — ways to support the recruitment, development, and retention of a diverse, research-ready workforce.
- Have you thanked your clinical research professional today? The critical, underpinning work of the clinical research professionals in advancing medicines often goes unnoticed. Let’s change that.
- Do you have standard operating procedures for hiring diverse staff? If not, what is preventing this critical “stake in the ground” step to make your organization’s staffing mix more reflective of the population of the community(ies) in which you are based?
- Although size is no barrier to the willpower to make a difference, some of the largest sponsors are taking concrete action in this arena as we speak. For example, in a move to both strengthen and diversify the clinical research workforce, ACRP in October announced a collaboration with Merck to provide access to training for clinical research sites located in historically underrepresented communities and for students interested in the clinical research profession. The collaboration is designed to empower local communities through direct engagement with high schools and community colleges and through support of clinical research sites.
- Such diversity-focused initiatives are (or should be) well within the reach of many more sponsor organizations and can be expected to benefit recruitment efforts among underrepresented patient populations as well, since participants want to see themselves reflected in the makeup of the clinical study team.
- What is your organization’s experience requirement for onboarding new talent? If you require a high level of education and experience, why? What are you trying to de-risk as a result of this requirement?
- Have you reached out to existing organizations in your community such as job networking centers, schools and universities, patient advocacy groups, and healthcare facilities not yet involved in clinical trials to share the good news about the clinical research profession? If not, there’s a career day in your future, I hope.
It is also important to note that strengthening the clinical research workforce is as much a matter of educating and attracting young, entry-level aspirants about and to the field as it is a matter of welcoming and preparing lateral movers from allied areas of healthcare or other industries. Aimed at both groups, ACRP has launched the “Ready, Set, Clinical Research!” toolkit, designed for flexible use by career advisors, recruiters, employers, and other stakeholders with a vested interest in the growth and diversification of the clinical research workforce. It points out that some entry-level positions are open to high school and college graduates through job postings that include no minimum experience requirements. CRC and clinical trial assistant jobs are common entry points, beyond which the possibilities are limitless, based on the individual’s interests and additional educational background. Meanwhile, lateral movers with established skills in such realms as healthcare, pharmacy, data analysis, project management, written/verbal communication, finance and legal specialties, and team leadership will find themselves valued in their new roles on clinical trials teams. In a related effort, and to the benefit of stakeholder organizations, the ACRP’s Early Talent Training Program allows sites, CROs, academic and health institutions, and sponsors to more quickly onboard those who are new to clinical trials and who have the right skills to succeed in the profession.
In the interests of a thriving and vibrant workforce — ready to meet today’s high demand for clinical research and ultimately serve the medical needs of millions of people — let’s work together toward a more insight-driven, more modern, more enlightened approach to hiring people in our industry.
- Gartner – Talent Neuron Reporting
About The Author:
Susan P. Landis joined ACRP as executive director in June 2021. Her more than 25 years of experience in organizational leadership includes time served as vice president, Quintiles, where she helped build and lead a global clinical research engagement group. Most recently, she served for six years as head of strategic engagement & communications at Duke Clinical Research Institute, where she led external and internal marketing for the world’s largest academic research organization.