Site Turnover: A Hidden Threat to Clinical Trials and How Sponsors & CROs Must Help

The COVID-19 pandemic has significantly affected clinical trials, amplifying existing research site challenges, particularly those related to staff turnover. Staff turnover rates at site networks have doubled on average relative to those prior to the pandemic, according to the Society for Clinical Research Sites (SCRS). As research sites begin to bounce back from pandemic-induced staffing shortages, they face a daunting combination of new employee onboarding and access management concerns.

Clinical research coordinators (CRCs) are at the center of this issue, experiencing high turnover rates that have serious implications for the research sites that employ them and the clinical trials dependent on their expertise.

If they're to be successful, sponsors and CROs must recognize site turnover as a hidden threat to their clinical trials and proactively seek solutions to support their research site partners.

In this article we'll cover what those challenges are, and how you can help.

Turnover Challenges at Research Sites

Research coordinator turnover specifically presents a significant challenge, as many coordinators inevitably seek higher-paying roles within CROs or pharmaceutical companies. In certain markets, CRA or data management jobs are a popular stepping stone as they can double a research coordinator's income.

This turnover is an unfortunate yet prevalent reality, as coordinators face limited advancement opportunities at most sites and rapidly reach a career ceiling in terms of both professional and financial growth. A 2021 survey by the Society of Clinical Research Associates (SoCRA) revealed that 68% of CRCs have held their positions for less than five years, highlighting the high turnover rate.

As a result of the high turnover, research sites must persistently train and prepare new, often inexperienced coordinators to manage essential, increasingly complex research studies from day one, ensuring trial timelines remain on track and preventing delays. 

Why should study sponsors and their CRO partners be concerned? 

Site staff turnover is not just a problem that sites alone must solve. While there is no specific data that quantifies the exact impact of staffing turnover on clinical trial timelines, there is evidence suggesting that staff turnover, particularly among clinical research coordinators (CRCs), can negatively affect the overall performance of a clinical trial.

A study published in the Journal of Clinical Oncology in 2019 showed that CRC turnover is associated with a decrease in patient accrual to clinical trials, with sites experiencing high CRC turnover having significantly lower patient accrual rates compared to sites with low CRC turnover.

High staff turnover can cause disruptions in trial activities, such as delays in patient recruitment, data collection, and study management. The time needed to hire and train new staff members, coupled with the learning curve experienced by new hires, may result in setbacks in the trial timeline.

New Employee Onboarding and Access Management

From day one, when the new coordinator's first patient arrives, it's crucial to ensure they have access to the necessary technology systems. However, obtaining access to these systems can be a challenging process. The delay between a site losing a coordinator and the CRO or sponsor becoming aware that a replacement has been hired can take weeks at best. As a result, gaining credentials for the 10 or more mission-critical systems also experiences significant delays. Simply identifying which systems are used for each study can be a frustrating endeavor for both the responsible CRA and the site. 

Additionally, data security risks arise when ensuring a departing coordinator's credentials have been removed from all systems. In 2019, a California-based clinical research site suffered a data breach after a former employee stole login credentials and accessed patient data without authorization.

Site owners have the ability to revoke access to the platforms they own, but it is typically the responsibility of the CRA to ensure that departing coordinators' access is removed from the majority of sponsor-provided software systems.

However, this process can often be delayed due to the CRA's demanding workload, a disjointed feedback loop, and the reliance on email as the primary channel for communicating staffing changes. These delays can lead to potential data security risks and further complicate the overall management of clinical trials.

To mitigate these challenges, it is crucial for sponsors and CROs to establish more efficient communication and access management systems, ensuring that site staff transitions are handled promptly and securely.

How VersaTrial Can Help

VersaTrial, a study assistant and organizer that complements other technologies, can tackle these challenges.

Here's how VersaTrial can make a difference:

Faster and Easier Onboarding: When a new coordinator is hired, their onboarding can be expedited by granting immediate access to VersaTrial's platform, where bookmarks to every study technology and external contact information are already organized for each individual study. This process also simplifies the identification of the systems the new user needs access to and training on. 

Improved Access Management: With VersaTrial, the CRO or Sponsor can be promptly alerted of a departing site employee, accelerating the removal of credentials and closing the loop on potentially significant security risks. Simultaneously, they can be made aware of a newly hired replacement, reducing the time required to provision credentials for essential study technologies. This streamlined process ensures seamless access management and enhances overall data security.

Reduced Burden and Increased Job Satisfaction: Integrated into the user's existing web browser, VersaTrial serves as a centralized platform for site teams to organize and collaborate on study-specific technology bookmarks and key contacts. With all crucial information for running a study at their fingertips, staff can concentrate on protocol tasks, quality checks, and patient visits. VersaTrial's built-in password vault further reduces the technology burden and eliminates the need for extra software or plugins. A recent UserEvidence survey shows VersaTrial users experience improvements in speed and productivity (92%), reduced burden (65%) and increase in job satisfaction (38%).

As research sites recover from the pandemic, it's essential that their sponsor and CRO partners find innovative solutions for addressing site staff turnover and its associated challenges. VersaTrial, the smart study assistant for research sites, presents a streamlined approach to simplifying onboarding, enhancing access management and credentialing speed, and bolstering data security.

By tackling these issues head on, we can minimize costly delays and effectively maintain trial timelines.