Job Overview:
Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
Summary of Responsibilities:
Coordinate and oversee site start-up and activation activities in compliance with ICH-GCP, local regulations, SOPs, and study requirements
Identify, assess, and engage potential investigative sites, including feasibility and initial outreach activities
Manage collection, tracking, and quality review of essential site and regulatory documents
Support IRB/IEC submissions and maintain ongoing site regulatory compliance
Collaborate with study teams, CRAs, vendors, and regulatory partners to achieve study milestones
Track start-up progress, manage timelines, identify risks or issues, and escalate as needed
Support site onboarding activities including PSV follow-up and SIV preparation
Maintain inspection-ready TMF and ensure systems and audit compliance
Serve as the primary point of contact for sites, ensuring timely communication and delivery aligned with study scope
All other duties as needed or assigned
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