Many companies are looking to hire these days, but are finding that few candidates are walking through the door. Clinical trial sites are no exception, particularly when it comes to filling open clinical research associate (CRA) positions.
“Rather than at entry level, we are observing that the shortage is more pronounced at the experienced CRA levels. This trend became apparent during, and continued after, the COVID pandemic,” said Helen Yeardley, senior vice president of global clinical operations at ICON, a global contract research organization (CRO). Trials are also struggling to fill other roles related to site start-up, clinical trial management, clinical operations management and data management, she said.
The pandemic may have exacerbated staffing shortages, but structural weaknesses existed well before it began. In 2015, the Association of Clinical Research Professionals (ACRP) described brewing problems in a report. At the time there were some 10,000 open CRA positions in the U.S. and no signs of improvement on the horizon.
“The shortage is creating inefficiencies for clinical trial sponsors and (CROs), many of whom find themselves in a constant recruitment cycle for qualified CRAs in a hyper-competitive job market,” report authors wrote.
The report authors noted that a third of CRAs who responded to a 2015 CenterWatch/ACRP survey said they planned to leave their jobs within a year, citing factors such as ever-growing responsibilities and a heavy workload that made it hard to attain a work/life balance.
Then came the COVID-19 pandemic and on its heels, the mass exodus of workers often referred to as the “great resignation.”
It’s a challenge that’s been tracked by the Society for Clinical Research Sites (SCRS). According to the group, in the first two quarters of 2022, the largest proportion of CRAs giving notice were those with more than 10 years of experience — a reversal of past trends where less experienced workers were more likely to resign.
“The current resignation rate of employees with a five-to-10-year tenure is 60% higher than in 2020. For employees with a 10-15 year tenure, it was 55% higher in 2021 than in the same period of 2020,” according to SCRS.
SCRS, citing data from Career Builder, also said that there are only 5.7 million people available for hire in the clinical research arena — but 6.6 million open jobs in the field.
Despite these stats, some question whether it’s really a shortage of experienced CRAs or merely a result of how their workplace operates. High-performing CRAs rarely scour the want ads, but rather move from job to job within the same organizations or use word-of-mouth referrals. In some instances, job openings may be artificially inflated by companies fishing for applicants without an actual opening to fill. Additionally, some jobs may stay vacant because the companies advertising them have earned a reputation as challenging to work for.
Still, Yeardley notes that the pressure on clinical trial professionals appears to have intensified, as demand for highly skilled CRAs has skyrocketed.
“As more complicated scientific assets and/or targeted therapies are developed, the clinical trial data volume has risen in scale and complexity,” Yeardley said. “We have also seen a significant increase in the number of sites and patients, which is in part due to the increase in trial patient sizes since the early 1990s. This requires more monitoring time, despite efforts to move to SDR (source data review) versus SDV (source data verification),” Yeardley said.
Improving the hiring pool
Staffing struggles may delay new studies from opening, drive up costs, and make it more difficult to meet regulatory and other study requirements. What can companies do to help ease the current staffing crunch?
“Constructively, a lot of organizations — CROs, pharmas and biotechs alike — decided to invest in a grow-your-own strategy,” Yeardley said. “This meant taking on less experienced staff, training and mentoring them, developing training and simulation programs, and overseeing them to a level at which they were able to monitor independently. This is a significant investment and will take time to alleviate the shortage, but we are seeing progress in the right direction.”
ICON is leveraging several strategies to cultivate a more robust workforce, Yeardley said.
“The focus is on attracting candidates who can quickly evolve to a CRA role from a variety of backgrounds and disciplines and ensuring they receive training and support tailored to their circumstances, and to the stage of their career,” she said.
The company also tailors training programs to each CRA’s needs.
“Having started as a CRA myself, I know firsthand the career opportunities that working as a CRA can unlock."
SVP, global clinical operations, ICON
“Each of these offer a comprehensive curriculum, including online and best-in-class instructor-led training workshops to lay the foundational knowledge of clinical research. Importantly, these also include hands-on experience in the form of accompanied site visits, mock visits, simulation visits, and individually tailored coaching, mentoring and skills development,” Yeardley said.
The goal is to help CRAs not only attain the technical expertise they need, but also those crucial soft skills that help them forge strong working relationships with sites.
“The ‘mock’ part of our training allows for an objective assessment of progress, along with targeted identification of development needs,” Yeardley said. “The coaching and mentoring part of our curriculum, while subjective, is particularly important to foster skills that build strong relationships across all levels of staff at sites.”
Making broader shifts
Still, the industry needs to change its mindset when it comes to hiring, Yeardley said. In particular, organizations need to move away from the idea that tenure is the only measure of competence. Providing real-world lessons on an accelerated schedule can enhance competence and help qualified CRAs enter the workforce more quickly to fill open slots.
More also needs to be done to retain existing workers and these new hires.
For instance, decentralized clinical trials (DCTs) can offer a means of improving working conditions for CRAs. One of the more challenging aspects of CRA roles is that they require frequent travel to review source data, which is a deterrent for some.
"In addition to immediate solutions that will help alleviate the resource constraints, we also need to take a long-term view as the industry undergoes significant change."
SVP, global clinical operations, ICON
“Technology and digitization have a significant impact on how clinical trials are carried out,” Yeardley said. “Using technology applications allows for the collection of digitized data from patients in a faster and effective manner; but it also may give CRAs remote access to data.”
To help cut down on CRA travel, ICON uses a remote CRA hub to allow more experienced CRAs to perform data review or even manage sites remotely.
“A key objective of the hub is to provide access to highly experienced and specialised CRAs in a cost-efficient way,” Yeardley said. “ICON has several off-shored hubs in lower-cost locations, chosen based on availability of clinical-research experienced CRAs, along with availability of infrastructure to support a remote team. Hub CRAs collaborate and work closely with in-country traveling CRAs.”
The industry also needs to spread the word about the benefits and opportunities of working in clinical trials.
“Having started as a CRA myself, I know firsthand the career opportunities that working as a CRA can unlock. CRAs can go on to build varied and fulfilling long-term careers in clinical research using the CRA level as an entry-level role — from clinical operations and project management to working in specific therapeutic areas,” Yeardley said. “Overall, working in clinical research is hugely rewarding, and CRAs play (a) fundamental and hugely important role in (the) clinical trial process. The resulting sense of purpose and job satisfaction, in my view and from my own experience, should not be underestimated, and is a compelling message.”
Despite the company’s efforts, Yeardley predicts that the issue of shortages is going to persist for some time.
“In addition to immediate solutions that will help alleviate the resource constraints, we also need to take a long-term view as the industry undergoes significant change,” she said.
How this problem will look in the future will depend in large part on how well the industry navigates its ongoing evolution, in particular the move toward DCTs, which will bring fundamental changes to how CRAs operate.
“This may make the role of the CRA as we know it today vastly different, incorporating elements of a data monitor, data analyst and risk analyst among others,” Yeardley said. “How we respond through training, learning and development supports will be hugely critical.”