CRC Turned Clinical Research Site Director Turned Consultant At Veeva Systems Talks Key Site Issues

This video explores critical operational aspects of clinical research sites, featuring Savannah Erickson, a consultant at Veeva Systems, who shares her journey from a Clinical Research Coordinator (CRC) to a Site Director and her current role. The discussion highlights the complexities of managing high-volume studies, optimizing CRC workload, and navigating interactions with sponsors and CROs. A central theme is the industry's ongoing transition from paper-based systems to electronic regulatory platforms, with a specific focus on Veeva Site Vault. Savannah emphasizes the importance of sites maintaining robust internal processes and confidently pushing back against mandates that could lead to inefficiencies, while also touching upon the challenges of CRC burnout and talent retention within the industry.

Key Takeaways:

• Digital Transformation in Site Operations: The clinical research industry is undergoing an accelerated shift from paper to electronic regulatory systems (e.g., Veeva Site Vault), which is becoming essential for operational efficiency, compliance, and future business development opportunities for sites.
• Site Autonomy and Pushback: Sites, especially those with established quality processes and deep protocol knowledge, should confidently push back against sponsor/CRO mandates (e.g., specific source document templates, deviation interpretations) that may create dual work or inefficiencies, advocating for their own proven, compliant methods.
• CRC Workload and Burnout: Managing high CRC workloads requires strategic prioritization, starting with patient safety, followed by study-specific enrollment priorities. High pressure and workload contribute significantly to CRC burnout, influencing experienced professionals to seek roles in tech or sponsor organizations.
• Robust Internal Systems for Compliance: Efficient site operations rely on strong internal quality assurance and regulatory departments, proactive monitor visit preparation, and daily operational meetings to ensure continuous inspection readiness and seamless management of multiple studies.
• Leveraging Academic Talent: The clinical research sector offers valuable career paths for advanced degree holders (e.g., psychology masters) in specialized roles such as psychometric raters at CNS sites, providing an alternative to traditional academic careers and addressing specific industry needs.