A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Clinical research associate (CRA) competencies are key to creating and nurturing this relationship under all circumstances.
“The CRA acts as a bridge between the site and the sponsor,” explains Amine Sehboub, BSc, PgD, Pharm, a Clinical Research Associate at Syneos Health. “Clinical research programs often run for many years, making a good relationship with the sponsor essential.”
“The process of building a robust relationship between the site/CRA and sponsor is similar to that for any other relationship,” notes Lisa Ince, BS, CCRC, CCRA, ACRP-PM, FACRP, a Project Manager at Syneos Health. “Using the bridge analogy, we need to build a solid, trustworthy bridge out of the right materials, taking into account who will use the bridge and what their needs may be. We can learn from our personal relationships to build strong partnerships within our clinical research lives. It’s particularly important as a CRA to be collaborative and compassionate rather than accusatory. Part of our job is identifying errors, but we must come to the table ready to support the site with solutions.”
Sehboub explains that CRAs establish trust using a variety of approaches. “It is important to show vulnerability, asking questions when necessary and admitting to mistakes,” he says. “Acknowledging other team members’ contributions is also vital, showing that all contributions are valued. We must also build personal connections to strengthen relationships, while offering support and resources to team members.”
CRA responsibilities include ensuring that patients’ rights are respected, facilitating problem-solving and conflict resolution, helping sites stay on track with factors such as data quality and regulatory documentation, and ensuring clear and consistent communication. This builds on the essential contributions at sites from clinical research coordinators, who focus on patient recruitment and enrollment, maintaining regulatory compliance, and study coordination and communication.
Defining the Role of the Clinical Research Associate in Site-Sponsor Relationships
Join Amine and Lisa at ACRP 2025 [April 24-27; New Orleans, La.], where they highlight the importance of establishing and maintaining a healthy relationship between sponsors and research sites. View complete schedule.
Transparency and reliability are essential characteristics, notes Sehboub. “CRAs should be sure to match actions to deliver on commitments and build credibility,” he says. “Transparent decision-making is also essential, in terms of clearly explaining the rationale behind decisions, especially those that impact the sites. We should act as the sites’ advocate with detailed documentation of actions taken by sites to resolve issues. Finally, we should provide training and resources to help sites maintain compliance.”
Ince concludes, “Throughout the study lifecycle, CRAs can help ensure that sponsors and sites work harmoniously together to achieve common objectives, optimizing the effectiveness of clinical trials through strong, cooperative relationships built on mutual respect.”
Edited by Jill Dawson
