By Andrea Bastek, PhD, Senior Director of Innovation at Florence
Whether you’re a Clinical Research Associate, Research Assistant, or Clinical Research Coordinator, working in the clinical trial industry isn’t easy. Most positions require detailed regulation, protocol, and disease state knowledge, attention to detail, and the ability to maintain meticulous documentation–not to mention project management, IT, collaboration, and interpersonal skills.
With all the diverse skills that clinical research staff are expected to have, it’s easy to see why industry burnout is reaching crisis levels. 67.7% of clinical research staff say that stress adversely affects their work performance, and the average CRA turnover rate hovers around 30%.
If we want to help clinical trials move quickly, collect high-quality data, and protect patient safety, we need to reduce burnout and turnover among clinical research professionals.
Kunal Sampat of the Clinical Trial Podcast, Benjamin Karsai of Monroe Biomedical Research, and my team came together at Florence’s quarterly Innovation Summit to discuss how turnover impacts the clinical research industry, and how we can combat burnout and turnover through people-oriented and tech-oriented solutions.
And if you’d like to learn more about the Florence community, check out our Research Revolution conference, coming this November.
The impact of clinical trial turnover
Clinical trial staff turnover impacts:
- Relationships between sites, sponsors, and CROs
- Data quality
- Site performance
- Study timelines
- Patient experience
If we can’t cut down on turnover, we risk less efficient, less patient-centric, and less high-quality clinical trials.
Relationships between sites, sponsors, and CROs
As Benjamin Karsai pointed out, sites are negatively impacted by high CRA turnover rates. Building relationships with new CRAs takes time, and sites often grow frustrated when CRAs ask to check on documents or data that previous monitors already looked at.
The opposite is also true: sponsors and CROs suffer when sites have high turnover rates. 63% of sites have challenges maintaining their workforce, according to the 2022 SCRS Oncology Site Solutions Summit. Losing experienced site staff causes stress for CRAs and makes it harder to find essential regulatory documents and source data. Sites could also take longer to produce documents, and the quality of those documents could suffer.
New site staff also require study-specific training from CRAs, which creates a heavy workload for CRAs and takes away from other required CRA tasks like monitoring.
Technology can make a tremendous difference in this area. 71% of CRAs say it’s easier to replace other CRAs when sites store their documents and data in a central remote platform. Document lapses are less likely to occur, and CRAs can reach out to new staff more quickly about document needs or training.
Data quality, site performance and study timelines
Turnover at sites, sponsors, or CROs can lower the data quality of studies and raise the risk of compliance errors. For example, an adverse event could be reported too late because the person meant to report it left the site or because an inexperienced CRA failed to catch the oversight.
Losing staff can also lead to eligible patients missing enrollment opportunities. 80% of U.S. research sites need an extension to meet their recruitment goals–and when sites miss their deadlines, the entire study suffers from delays that can cost sponsors $600 thousand to $8 million per day.
When we talk about clinical trial staff turnover, we often forget to consider how it impacts patients. Patients choose to participate in a clinical trial because of trust: trust in the research staff and clinicians, in the new drugs or technology being offered to them, and in the medical system conducting the trial.
The NIH asked real patients why they chose to join clinical trials, and patients with an illness were most likely to say it was to receive the newest treatments and to spend more time with clinical trial staff.
When research staff suddenly leave, it damages those patient relationships. It can also impact enrollment rates as new staff take time to build the knowledge and rapport that leads to successful recruitment.
One attendee commented “Site turnover can ultimately cause a decrease in interest in clinical trials for patients who were hesitant to participate in the first place. Those patients build rapport and trust with CRCs.”
Finally, patient experience in clinical trials is often a grassroots mechanism for recruitment. If staff turnover creates a negative experience, patients are much less likely to refer other members of their community to participate.
Solutions to clinical trial turnover
In Benjamin Karsai’s words, clinical research is a “fundamentally human enterprise.” It relies on participants to generate the data needed for studies to be successful, and that won’t change anytime soon.
Even as we move toward more decentralized trial models, physicians, CRCs, and the bonds they form with participants will continue to play a vital role. As the number of clinical trials grows, the need for passionate staff also grows, with open clinical trial positions growing 5.8% year over year.
So when we try to solve the problem of clinical trial turnover, the solution isn’t replacing people with tech. It’s helping clinical trial staff grow in their careers and giving them technology that will help prevent burnout.
Recruiting clinical trial staff and helping them grow in their careers
Solving the burnout problem in the clinical trial industry will take:
- Creative recruitment practices
- Awareness about the industry
- Intentional career growth strategies
1. Creative recruitment practices
Research sites who suffer from constant turnover often are afraid to talk about the job for fear people will leave quickly due to a lack of growth. Therefore, they don’t engage in effective recruitment–and many candidates perceive research coordinator jobs as not having the potential for career growth.
But research coordinators gain “fundamental knowledge and expertise that has a huge impact on the industry and patients,” says Benjamin Karsai. “The best monitors and CRAs usually have CRC or site experience.” In other words, they understand the reality of study-site operations and are true advocates for sites and participants.
Sites shouldn’t be afraid to recruit, internally or externally–and when they do, they should send the message that an entry-level research coordinator or research assistant role builds a strong foundation for a long career in the clinical trial industry or medical field.
2. Awareness about the industry
At Monroe Biomedical Research, cofounded by Benjamin Karsai, they made a strong and intentional paradigm shift in their hiring strategy. They started looking for candidates with some medical or patient experience but didn’t require a particular degree or any research experience–thus raising awareness about clinical research among people who didn’t already work in the field.
Karsai suggests that the clinical trial industry should put greater emphasis on motivation, enthusiasm, a desire for responsibility, and an eagerness to work with patients. This might also mean giving opportunities to career-switchers or young people who are just starting out in their career, and then helping them learn about clinical research.
3. Intentional career growth strategies
Across the industry, many clinical research staff are not given opportunities for professional development. 74% of Clinical Research Coordinators thought about changing jobs in 2020, and one of the top reasons was a lack of recognition and growth.
Our team suggests that managers ask themselves, “What have I done to help the CRCs/CRAs who report to me?” Managers or directors can advocate for resources and opportunities that can empower and support staff, from skill set development to educational or networking opportunities and leadership roles on special projects.
At the same time, study staff should be proactive in considering their career path. As Kunal Sampat put it, “you have to take charge of your career development.” He suggests certifications and classes from local colleges or from ACRP and SOCRA.
CRCs could also explore courses in general tech, organizational, project management, and communication skills (many of which we offer through the Florence Digital Research Academy!)
Sponsors and CROs can help with career growth too. Since CRC and CRA retention benefit sites and sponsors, sponsors could offer funding to send staff to conferences, provide training that includes CEUs, acknowledge exceptional site staff in newsletters or study meetings, and involve site staff members in planning and feedback sessions to give them agency in the study.
But staff recruitment and retention strategies alone won’t be enough to keep up with the rapid growth of clinical trials. If the industry continues to grow at its current rate, we will need 20,000 new CRAs by 2030–unless we can find ways to increase CRAs’ productivity.
Technology Solutions for Turnover
Technology can help CRCs and CRAs become more efficient and prevent burnout–but only if that technology is intuitive and easy-to-use. In the past, sponsors and CROs have made the mistake of piling technology onto sites without checking to see if that technology genuinely makes their lives easier.
Data from SCRS shows that 57% of sites believe clinical trial technology makes staff more efficient–but 30% of sites believe it makes them less efficient. Benjamin Karsai, Kunal Sampat and the Florence team all agreed that sites deserve site-friendly technology, not just technology that saves sponsors money.
If tech providers truly want to help sites, they need to offer excellent customer support, a high-quality user experience, and support for site SOP revisions. Sponsors should ask technology vendors what their implementation process looks like before selecting a specific form of technology. Sites and participants should also be included in study planning and technology selection.
But the right technology can lead to greater efficiency and less burnout. 78% of CRAs can get documents into the eTMF faster with the help of remote site access technology, and 71% say technology makes taking over for another CRA easier.
Sites can also benefit from the right technology. One site network experienced a 42% reduction in document cycle time and a 49% acceleration in study startup with site-friendly technology.
Technology alone can’t solve the problem of burnout–but user-friendly technology that’s intuitive for sponsors and sites alike can help.
Fighting Burnout and Turnover with Career Growth and Technology
If we want to solve clinical research’s staffing problem, we can’t just continue posting jobs online. We need to work on addressing the problem of burnout and turnover by giving clinical research staff the chance to grow, expanding our recruitment criteria, and offering technology that reduces routine, repetitive work instead of creating more tasks.
If you’d like to learn more about clinical research career development, consider attending the next Florence Innovation Summit (to be announced soon!) or joining sites, sponsors, and CROs at our Research Revolution conference, taking place this November.