What the “Great Resignation” means for clinical research

The “Great Resignation” has dramatically impacted the clinical research space. Turnover rates for clinical research associates (CRAs) now hover around 30%, while the number of open positions across the industry has increased by 9.3%.

Staffing shortages can slow down trial timelines and negatively affect patients, who have less time with the physicians and nurses providing their care. In the long term, educational and certification programs can raise awareness of clinical trials and draw more people into the profession. But in the short term, clinical research sites and sponsors need strategies for running trials efficiently and safely with limited staff.

This is where technology plays a vital role. Rather than frantically searching for new staff, sites and sponsors can combat the Great Resignation by using technology to help the staff they have complete more work in the same amount of time.

What’s causing the great resignation in clinical research

Clinical research professionals have undergone the same burnout and reevaluation of priorities that many workers experienced during the pandemic. But the stress of working in healthcare during a public medical crisis can make burnout even worse. Since the start of the pandemic, 76% of healthcare professionals have reported feeling exhaustion and burnout since the pandemic, versus 61% of all professionals who report feeling that way.

Research site staff often work long hours to accommodate investigators’ and patients’ schedules and strict trial timelines. During the pandemic, they suffered the additional strain of risking illness while caring for patients or conducting clinical research procedures.

Clinical research associates face a different set of struggles. CRAs spend roughly 60 to 80% of their time traveling, which can lead to high rates of burnout. CRA jobs in the U.S. have a turnover rate of 30%. By comparison, the overall turnover rate in the U.S. is around 19%.

Many clinical trial professionals also choose to seek new jobs because of limited growth opportunities. After spending a few years in clinical research, clinical research coordinators, project managers and CRAs often see their salaries plateau.

The combination of overwhelming workloads, emotional stress and lack of advancement leads to high turnover rates for clinical research.

The consequences of staffing shortages

In clinical research, staffing shortages can lead to long start-up timelines and missed deadlines, causing delays in the submission and approval of new treatments. For sponsors, the shortages also lead to delayed monitoring visits, which slow down trials and prevent CRAs from spotting errors as early as they should.

One project director at a large CRO told Clinical Research Strategies, “I am constantly dancing around the fact that I don’t have CRAs, and especially anyone who understands how to monitor difficult oncology trials. I can’t do this anymore.”

When clinical research professionals experience the stress of not having enough staff, they become more likely to resign themselves, creating a vicious cycle.

Staffing shortages also worry patients. In a survey by the Emergency Care Research Institute, patients listed staffing shortages and workers’ mental health as their top two healthcare safety concerns. In another survey, 89% of nurses and healthcare workers at one health system worried that staffing shortages were compromising patient care. These concerns about clinical care could turn patients away from clinical trials and other lifesaving treatments.

So how can clinical trial organizations protect patients and help their teams, even if they can’t afford to hire more staff?

How to cope with staffing shortages using integrated technology 

Ideally, clinical trial organizations would be able to attract abundant talent with incentives like higher salaries or flexible working hours. But realistically, small sites or contract research organizations (CROs) can’t always offer salary increases, and the needs of patients and investigators often require staff to work long hours.

The dramatic mismatch between supply and demand for clinical trial professionals also means that not all organizations can find new staff, even with high salaries.

But every sponsor, CRO and site can empower regulatory staff to use their time well. We need to give clinical trial professionals time to focus on what matters—patient care—and take away time spent on repetitive data entry and document management.

The problem? Clunky or redundant technology can add more work instead of taking it away.

For example, healthcare providers spend a disproportionate amount of time—approximately 5 out of 8 clinical hours—inputting data into their electronic health record (EHR). They then spend 2.4 hours additional hours entering data after the workday is over.

Now think of the problem this presents for clinical research staff, who often work not just with an EHR but with an electronic Investigator Site File (eISF), an electronic Trial Master File (eTMF), a Clinical Trial Management System (CTMS), and many other programs, depending on the study.

The importance of integrations

Integrated systems solve the problem of repetitive data entry. If sites have a CTMS that integrates with their eISF, for example, they can enter data into one system and access it within the other.

This is why open-API systems are so critical. Systems with an open API can integrate even if they come from different software companies, which gives sites and sponsors the freedom to choose the systems that work best for them.

The importance of remote access between sites and sponsors 

Clinical research technology also needs to connect sites to sponsors. In the past, sites would have to adopt a new technology system for every study or upload documents into multiple clunky sponsor portals.

The Great Resignation means that sites don’t have enough staff members to waste time with repetitive uploads. But monitors still need the ability to see sites’ documents and data online in between monitoring visits.

The solution? Site staff can use software that makes it easy to store their documents and data. Then, instead of uploading their documents into a portal, they can grant sponsors access to that same system.

The ability to access documents and data remotely will save monitors hours or even days spent traveling. CRAs can quickly check on documents and data in between site visits and spend their on-site time focused on participant safety and the needs of site staff. This won’t just help trials run more efficiently—it will also protect CRAs from feeling burned out because of excessive travel.

Overcoming the great resignation in clinical research

Clinical trials can’t stop running because of staff shortages. But as clinical research professionals become more overworked due to those shortages, their burnout rates rise, creating even more turnover. Higher salaries, more flexible schedules and educational programs may help attract new people to clinical research. But as long as the demand for clinical research professionals exceeds the supply, shortages will persist.

This is where technology comes in. Dozens of complex, separate technology solutions won’t help speed up clinical research. But a few flexible, integrated systems that work for both sites and sponsors could. Clinical research organizations need to search for these systems, and technology vendors need to create them.

Photo: gorodenkoff, Getty Images

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