Clinical trials faced staffing issues prior to the pandemic. In 2019, the average unemployment rate for clinical research associates (CRAs), in particular, stood at 2.54%. Adding to this challenge were pandemic-related issues that disrupted nearly 58% of traditional clinical trials.
Now, as trials ramp up again, talent shortages remain. In the first quarter of 2022, more than 50% of sites cited staffing as their top issue. This lack of personnel impacts all aspects of the clinical trial process, from enrollment timelines, testing capacity, and trial deadlines to approval submissions, monitoring efficiency, and error identification.
As a sponsor, creating a lasting solution calls for working together with the clinical research organization (CRO) and the site to overcome the hiring challenges impacting trials. However, there are small measures you can take independently to support CRO latitude in determining the best resources and staffing models for the job, even as shortages continue.
Why Site Shortages Persist
Though most CRA positions require at least two years’ experience, the problem is that the majority of talent available to fill these roles is further along the career path. Sixty-three percent of the CRA population is over 40.
This “over-experience” means most individuals are past the point where they are willing to take on grueling travel schedules and are instead interested in opportunities that grow their careers.
This is compounded by the fact that many of the more experienced workers who could staff clinical trials are retiring or opting for career changes, both of which were accelerated by the pandemic. So it’s no surprise the turnover rate for CRAs in the U.S. is at an all-time high of 30%.
This perfect storm of circumstances leads to an inability to fill the front end of the talent funnel and maintain a balance of entry-level, billable workers. While there’s not a blanket solution that could solve all of these hiring challenges, there are a few changes sponsors can consider to help increase the pool of available CRA applicants.
How Sponsors Can Help Temper Talent Strain
Today’s talent shortage is an extension of what’s been happening since the mid-2010s. It’s compounded by the fact that the ability to gain relevant industry experience far under paces industry growth.
Sponsor companies can have an impact by shifting how they approach CRA hiring requirements and by working differently with sites and CROs on how trials are staffed.
1.) Recognize Transferable Skills.
With fewer CRAs in the talent pool, and those that remain skewing to an older demographic less prone to travel, it’s time to think outside the box when it comes to required skills.
It’s not so much that there is a lack of individuals interested in CRA positions, but rather that very rarely is there a 1:1 alignment between applicant credentials and those listed as “must haves” in job postings. Case in point, many travel nurses, RNs, and clinical research coordinators apply for CRA roles. A good number have handled administrative coordination tasks for clinical trials, and most are willing to travel for two to three years to gain career experience. However, lack of practical experience within a CRA role often precludes them from consideration.
An applicant with most of the necessary skills, or skills that complement the demands of a CRA position, can prove a vital, untapped resource. The CRA role involves a fair number of administrative tasks. Splitting the role into two and hiring one person to handle strictly administrative duties while the other handles the more clinical aspects may be an option. If not, consider hiring a person who checks most of the boxes, understanding that the CRO can train the person on additional needed skills.
Taking advantage of those in the healthcare field who are willing to travel and fill CRA roles could help offset the impact of understaffing and ensure resources are allocated where most needed. For instance, therapeutic trials, such as oncology, require specific experience, while non-therapeutic trials may have looser parameters where transferable skills could be a good fit.
2.) Reimagine Experience Requirements.
In tandem with considering transferable skills is a reimagination of required experience parameters. Expecting a four-year education with accompanying certifications and at least two years of experience can limit hiring options. As a sponsor, taking a step back to reevaluate what experience level is really necessary can go a long way toward filling critical roles. This means trusting that the CRO understands your business and will resource it effectively. It also means acknowledging that life experience, as well as educational experience, can count in terms of building usable CRA skills.
What’s being seen in the industry now is that the experience required to fill a role cannot be gained without working in that role, but working in that role cannot be done unless one has experience. This challenging cycle can be helped by giving nurses and others with outside, tangential experience a chance. It’s a small way to increase hiring flexibility and help CROs limit roadblocks that prevent them from bringing new entry-level talent into the clinical marketplace.
3.) Reduce Service Complexity.
Talent shortages and a lack of experienced CRAs were an issue in 2019, as they are today. However, the cultural shift to remote work that resulted from the pandemic adds a new layer of complexity.
As a sponsor, leaning into technology advancements and process changes that simplify how trials are conducted helps you, and your CRO, better overcome hiring hurdles. For example, technology developments have made it easier to deliver services regionally, but often the requirement is still for local teams. Opening up to the possibility of remote work can help attract and retain more trial talent, especially those CRAs in older demographics who no longer wish to be road warriors.
The technology used at trial sites also can make a difference. As a sponsor, you’re typically responsible for selecting the technology that best serves your needs. Considering that “sponsors and CROs on average use three different systems to exchange trial data and documents with study partners,” it’s a good idea to thoughtfully evaluate the technology you select to minimize complexity. The less complex a trial is to conduct, the greater the chances of finding CRAs and others to staff it. This extends to trial protocol complexity, as well.
4.) Consider A Resource Manager.
As clinical trial complexities grow, resource managers are becoming more popular. A resource manager can keep closer tabs on all aspects of trial hiring and management — from understanding how the therapeutic specialties of the talent align with trial needs to knowing precisely when a trial is starting and stopping to make sure CRAs and others are not sitting idle between studies.
Trials involve a delicate balance of resource allocation against study requirements. Once you, as a sponsor, sign a contract with a CRO, it’s almost too late to start hiring. The process needs to begin sooner, and the hiring needs to happen ahead of demand. But the process also needs to account for allocating the right resources from the start. A CRA coming off a dermatology trial is likely not the right person to staff a just-starting oncology trial. A dedicated resource manager understands this and can help ensure workers remain active to prevent the temptation to seek work with other CROs.
As of June 2022, there were 133,087 clinical studies registered in the U.S. and 419,487 total globally. That’s up from 362,502 global studies registered at the end of 2020 and 399,526 at the end of 2021. The pace of clinical trials is accelerating. A strong talent acquisition strategy is critical to successfully conduct all trial phases. Broader solutions to permanently solve the long-term healthcare talent shortage have yet to emerge. In the meantime, the steps outlined in this article are concrete actions sponsors can take now to improve clinical trials hiring and help keep trials running in the short term.
This article was originally written for and published by Clinical Leader here.