Clinical directors don’t have it easy. While the number of contract research organizations has boomed in recent years — and growth isn’t slowing — there aren’t enough clinical research associates (CRAs) to go around.
The contract research organization (CRO) market is set to increase by between 7.4 and 8.2 percent annually until 2023; however, the number of CRAs available is far too low to meet that requirement, says Dietmar Eglhofer, cofounder of the Vienna Academy for Workforce Competence in Clinical Research. The blame starts with a lack of industry investment in new talent development, he says.
Another problem is the hiring practice of placing a stringent focus on the level of experience required to get a job, writes April Schultz at Forte Research. There were more than 10,000 open CRA position in the US in 2015, indicating how serious the work shortage issue is. However, “it’s likely this shortage was caused by the seemingly arbitrary, but common practice of requiring two years of professional experience for entry-level CRAs,” she explains.
Directors at CROs need to find ways to identify and attract CRAs and offer them space to develop. In this post, we explore what a CRA’s career development would look like and how CROs can support them in their roles.
Beyond the medical training itself and related experience, clinical directors should look for intrinsic qualities that move clinical research associates from competent to exceptional. CRA Elizabeth Blair Weeks-Rowe says some CRAs are effective communicators, able to translate complex medical processes into language that partners, stakeholders and patients can readily understand. Another talent to look for is the ability to provide superior data review, which requires diligence, a trait shared among successful CRAs.
The job is demanding, but clinical research manager Leigh Boxall says her colleagues and peers, regardless of their backgrounds, are in the industry for the same reason: to help patients by improving diagnoses and treatments. CROs can highlight the diversity of teams as a positive learning experience for CRAs but remembering why people work in the industry is useful for all parties.
A word of warning, however: A surprisingly high number of resumes submitted for CRA roles are fraudulent. Nearly 20 percent of CRA applications contain partially or completely false claims, says CRA recruitment executive Angela Roberts.
She explains there are organizations making money off this practice by providing services to create fake resumes, complete with false company websites, employee references and employment verification. They offer advice on how to cheat the application process with interview tips and a crash course in clinical trial lingo. Given the scale of the problem, Roberts cautions CROs to be diligent during the hiring process, looking for specifics such as:
Once the clinical research associate is hired, the next step is ensuring there is sufficient professional development to allow that employee to keep up with the industry’s changing demands. As new technology rolls out, clinical trial professionals need to develop new skills.
Speaking specifically about their experiences of moving from clinical research coordinators into their roles as CRAs, Marian Fisher and Thomas Boothby at Boston Scientific say the wide variety of monitoring models is a result of new technology and is essential to understand. Examples of different types of monitoring include risk-based, central and remote monitoring, and knowing their nuances is fundamental to a CRA’s success.
CROs, for their part, can help professionals develop in their careers. Fisher and Boothby cite the Association of Clinical Research Professionals as a worthy body from which to seek certifications and career progression qualifications. Many CROs have internal development programs too, which could provide CRAs with clear progression routes.
A good clinical research associate is wholly devoted to achieving study goals while maintaining high standards. Ken Boudreault, a CRA with 15 years of experience, says this requires a keen focus on compliance, specifically noting the importance of maintaining the trial management file.
He suggests having a dedicated documentation specialist on the team to take control of the TMF, which will allow for feedback on the study’s quality during review periods contrasted with the expectations laid out in the file. The TMF is also valuable in compiling monthly reports, which Boudreault suggests is a useful timeframe to focus on.
Clinical trial site staff want their CRO and sponsor partner to be well-organized. That means clear communication and reliable study design, materials and data, explains Association of Clinical Research Professionals executive director Jim Kremidas.
Site staff need someone to be able to find a fix when plans change, which is they value working with a CRA who is enthusiastic and competent and works with them rather than against them. The CRO needs to provide resources to ensure the associates can do their job and should also provide training for individual projects. This customized training would ensure that both the protocol required and the disease being investigated are fully understood, say Carolyn Stroud, founder and CEO of clinical research staffing firm Vigor BioPharma Solutions.
There have been major advances in clinical trials with remote-based monitoring tools and virtual trials, but travel will always be a major requirement for clinical research associates. CROs must make this clear. And while travelling is demanding, it can be made simpler to avoid burnout, says Joe Mills, senior director for the Global Recruitment Center with inVentiv Health Clinical.
CROs can help by classifying the CRA as a low-risk traveler with the Transportation Security Administration to speed up security screening, he explains. Also allowing CRAs to join airline membership clubs will give them access to travelers lounges and make layovers more restful and productive. Mills adds that it’s worth using travel algorithms to plan more efficient travel itineraries too.
The way CROs operate is fluid. Mergers and acquisitions abound in the industry and that means clinical research associates need to be flexible and responsive. That can be challenging, but Theodora Savlovschi-Wicks at ProClinical says CRAs can take charge of their careers.
One false belief holding CRAs back is that a different CRO employer will provide a similar experience to the last or current employer, she writes. In reality, CROs have different organizational structures and, depending on their size, can present many differences in scope and responsibility of the role. Protocols differ, as do systems and processes. But CROs will also work on vastly different studies and sponsors. CROs should be clear about what their organization can offer CRAs. Often, it’s a great deal of autonomy.
As pharma organizations continue to outsource important services and operations, broad and niche CROs alike present many opportunities to CRAs.
The opportunities are varied, but CRAs will learn a great deal on the job, explains Kunal Sampat at ClinicalTrialPodcast. This is especially so as many CROs are focused on internal professional development. But it’s not necessarily all positive and CROs should be candid about the job: It can be stressful and demanding, especially if working with a difficult sponsor. Still, the positives do tend to outweigh the drawbacks.
CROs are looking for clinical research associates who have the right attitude and relevant experience, but who also have a desire to learn on the job. Of course, the candidates need to be great communicators too, says the team at CRA Careers and Jobs.
Given the fierce competition for CRAs, clinical directors need to offer rewarding packages in the form of high remuneration, support and career development. The team at Hays Recruitment in Australia suggests adding flexibility such as working from home to the list.
The CRA role is rewarding but not without challenges. Succeeding in the role depends on the expertise and attitude of the person in it, but CROs can help ensure the duties, demands and perks are clearly defined at the outset.
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