More Than Just A Monitor: Are You Underutilizing Your CRA?

By Elizabeth Tabor, CEO, Clinical Research Referral Club

CRAs are essential to the success of clinical trials, ensuring protocols are followed, data is accurate, and regulatory standards are met. However, despite their critical role, many CRAs are confined to repetitive, transactional tasks that underutilize their full expertise and potential. Rather than leveraging their vast experience, they often find themselves restricted to basic monitoring duties. While these activities are undoubtedly important, they represent only a fraction of what CRAs can contribute to a trial’s success.

When CRAs are limited to these narrow responsibilities, it’s not only their career advancement that suffers, but also the sites they work with. Opportunities for operational improvements, enhanced efficiencies, and valuable process insights are lost. The result? Both CRAs and clinical research sites miss out on the chance to elevate trial performance and outcomes. This underutilization of CRAs' full potential is a problem that, when addressed, could unlock significant benefits for the clinical trial ecosystem.

The Vital Role Of A CRA

Before diving into the issue of underutilization, it's important to recognize the multifaceted role of a CRA. While monitoring and compliance checks are central to their role, CRAs also have the knowledge and skills to contribute to various aspects of a clinical trial. Let’s take a closer look at the core functions that CRAs perform:

• Site Monitoring: Ensure adherence to study protocols, maintain data integrity, and address discrepancies while upholding regulatory standards.
• Training and Education: Provide essential training to site staff on trial procedures, protocols, and documentation requirements, ensuring accurate execution.
• Communication: Act as the liaison between research sites and sponsors, facilitating clear and timely communication to align all stakeholders.
• Regulatory Oversight: Ensure trials meet all ethical, regulatory, and legal requirements from initiation to closeout, safeguarding compliance and patient safety.
• Cross-Site Insights: Offer best practices learned from multiple sites, helping individual sites optimize their own workflows and avoid common pitfalls.
• Data Quality Assurance: Proactively address potential data discrepancies and ensure compliance with Good Clinical Practice (GCP) guidelines.
• Patient Recruitment and Retention Strategies: Share recruitment insights and engagement tactics to enhance patient enrollment and reduce dropout rates.

Despite these important responsibilities, many CRAs are restricted to monitoring tasks, such as reviewing documents and verifying compliance. This narrow focus prevents them from contributing to trial optimization, process improvements, or offering strategic solutions.

The Underutilization Of CRAs: A Missed Opportunity

The underutilization of CRAs isn’t just a matter of inefficiency; it’s a missed opportunity for both the clinical site and the sponsor. CRAs possess valuable insights and a wealth of experience that could elevate the trial process. They work across multiple sites and interact with various teams, giving them a unique perspective on what works and what doesn’t in trial management.

However, when CRAs are relegated to basic monitoring duties, their ability to add value in other critical areas, such as optimizing workflows, improving patient retention, or sharing insights across sites, is severely limited.

CRAs Are Strategic Advocates For Sites

One of the most underappreciated roles of the CRA is their ability to advocate for the site with the sponsor. Often, the CRA is the only person who truly understands the challenges faced by site staff and the practical realities of trial management. When issues arise — whether related to staffing, resource shortages, or protocol challenges — the CRA can raise these concerns with sponsors, helping sites get the support they need to overcome obstacles.

Unfortunately, when CRAs are kept at arm’s length and confined to monitoring tasks, this advocacy role is diminished. Sites are left to navigate sponsor expectations and trial complexities without the critical support of a well-informed CRA, which can lead to increased frustration and inefficiency.

The Site-Specific Challenges Of Underutilizing CRAs

The challenges of underutilizing CRAs differ significantly depending on the size and infrastructure of the research site. Here’s how these issues play out at small and large sites.

Small Sites: Limited Facility Space And Monitoring Time

For small sites, space and time are often the most significant barriers to fully leveraging CRAs. With fewer staff members and limited facility space, small sites may struggle to accommodate all the tasks needed for efficient trial operations. Monitoring visits often must compete with other clinical activities, and the site may have limited space to properly set up for monitoring or store study supplies. As a result, CRAs may only have brief interactions with site staff during scheduled monitoring visits, leaving little room for deeper involvement or for offering valuable input on trial efficiencies, workflow improvements, or best practices.

This restricted engagement often means that small sites miss out on the opportunity to gain insights from the CRA’s experience with other sites or studies. The lack of time and space makes it harder to maximize the CRA’s potential for improving trial operations.

Large Sites: Difficulty Engaging Ancillary Teams

Large sites, such as academic medical centers, often face different challenges, particularly around their ancillary teams. While they may have more specialized staff and better facilities, the complexity of their operations can create silos that prevent CRAs from fully contributing. For instance, while CRAs may be scheduled to meet with the pharmacy team to complete investigational product (IP) accountability, their time is often limited to a specific time slot. There’s rarely an opportunity to provide additional training, answer complex questions, or offer guidance on systems or protocol updates. This lack of direct interaction with the ancillary teams, coupled with the absence of a pre-established relationship, can prevent CRAs from adding value where it’s needed most.

Without the opportunity to collaborate directly with staff or offer real-time guidance on system optimizations, CRAs are limited to monitoring compliance, when they could also be providing solutions to enhance workflow and trial efficiency.

The Consequences Of Underutilization

When CRAs are underutilized, the effects are not only felt by the CRAs themselves but also by the entire trial team, including sponsors. Here are examples of how underutilization impacts trial operations:

1. Missed Process Optimization Opportunities: CRAs can identify inefficiencies, such as when patient visits are scheduled too tightly without considering lab shipments. For example, by adjusting visit timings based on feedback from other sites, CRAs help streamline workflows, reduce delays, and lower costs. Their ability to see the bigger picture and suggest operational adjustments ensures the trial runs more smoothly.
2. Limited Access to Best Practices: CRAs are exposed to multiple vendor systems and often encounter solutions to common challenges at various sites. For instance, if a site is struggling with a new system, the CRA can offer insights on how other sites successfully set it up. This knowledge-sharing helps minimize errors and simplifies data entry, facilitating the site's adoption process and speeding up system integration.
3. Reduced Resource Allocation: CRAs frequently spot discrepancies in supply shipments, often based on the site's feasibility questionnaire responses. If shipments are too frequent or too scarce, they can help adjust the delivery schedule so that the site receives the right number of supplies at the right time. This optimization helps the site save valuable space, reduce waste, and allocate resources more effectively.
4. Compromised Data Quality: When a site falls behind on data entry, CRAs are typically the first to spot gaps in the data. By pinpointing these specific gaps, CRAs ensure compliance and timely submissions. They also clarify which data and milestones are critical under a risk-based monitoring approach, helping the site focus on what matters most and stay on track without being overwhelmed by less relevant tasks.
5. Delayed Issue Resolution: CRAs play a key role in resolving issues quickly. For example, if there’s confusion over investigational product handling or lab discrepancies, CRAs can provide immediate guidance, bypassing the study coordinator. This direct involvement accelerates problem resolution, prevents delays, and ensures protocol compliance without having to rely solely on study coordinators or wait for formal escalations.
6. Weakened Site Reputation: In the case of protocol deviations or other issues, CRAs add crucial context to monitoring reports. Without this insight, sponsors may misinterpret a situation, potentially damaging the site's reputation. However, with a CRA's explanation, the site's actions are better understood, preserving its credibility and reputation with sponsors, which can enhance the likelihood of being selected for future studies

Maximizing CRA Impact With Strategic Solutions

To fully leverage the skills and insights of CRAs, clinical sites must make a concerted effort to integrate them more deeply into the trial process. Here are some key recommendations for making the most of CRA interactions:

• Leverage CRAs as Site Advocates: Foster open communication with CRAs to help relay site challenges to sponsors. A strong CRA advocate can secure vital resources and operational adjustments for the site.
• Encourage Cross-Site Knowledge Sharing: CRAs bring valuable insights from other sites. Engage with them to adopt best practices in patient recruitment, regulatory compliance, and process optimization.
• Build Trust with CRAs for Increased Support: Strong, collaborative relationships with CRAs can lead to additional resources like extra staff, updated training, and improved technology, all without added costs.
• Use CRA Feedback for Continuous Improvement: CRAs offer actionable insights that can enhance compliance and efficiency. Sites that actively seek feedback — on both protocol and systems — can address issues early and drive meaningful operational improvements.
• Strengthen Site Reputation for More Opportunities: Sponsors value efficiency, responsiveness, and collaboration. Building positive relationships with CRAs boosts your site's chances of being selected for additional trials.
• Gain Early Access to New Trials: Strong relationships with CRAs can provide early insights into upcoming studies, giving sites a competitive advantage when preparing for new trials.
• Proactively Manage Protocol Deviations: CRAs help identify potential deviations early, enabling sites to address issues before they escalate into compliance risks or regulatory penalties.

Conclusion

Underutilization of CRAs is a missed opportunity for research sites. CRAs offer far more than just monitoring capabilities — they are advocates, problem-solvers, and strategic partners who can enhance trial efficiency and improve data quality. A site’s reputation, both with sponsors and within the clinical research community, is significantly influenced by the quality of its relationship with its CRA. By engaging CRAs more effectively, sites can ensure smoother trial operations, strengthen sponsor relationships, and increase the likelihood of securing more future studies.

About The Author:

Elizabeth Tabor is a dedicated clinical research professional with over six years of expertise in regulatory affairs and clinical operations. As the co-founder of a global platform, she is committed to advancing the clinical research field through collaboration, knowledge sharing, and patient-centered innovation. Elizabeth has built a network that unites diverse stakeholders to tackle industry challenges and drive meaningful change. By improving the visibility and accessibility of resources, she creates transformative opportunities for professionals, organizations, and patients alike. A passionate advocate for workforce development, Elizabeth is focused on increasing diversity within clinical research, advocating for a workforce that mirrors the communities it serves. Through strategic networking and effective communication, she fosters environments where professionals can collaborate, grow, and innovate. Her leadership continues to shape the future of clinical research, ensuring it remains inclusive, impactful, and responsive to the evolving needs of the industry.