Site Navigator II (Regulatory & Start up Specialist) - FSP

Job description

Job Overview: Site Navigators II plays 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 II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. This role serves as a local expert in project start-up/clinical activities for a particular country or region, performs work with limited oversight, and acts as a ‘knowledge resource’ to mentor and train junior colleagues if suitable. Summary of Responsibilities: Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to...