Site Navigator II

Job description

We are looking for a clinical operations professional to join our team as a Site Navigator II with a significant Start-Up experience. This is an excellent role for someone looking to grow their career in clinical research within a global CRO environment. Summary of Responsibilities: Act as the primary point of contact for investigative sites during the start‑up phase Conduct site outreach, feasibility and perform remote Pre-Study Visits Perform country Participant Information Sheets/Informed Consent Forms adaptation to French requirements Manage country and site level documents for Part II submission under EU CTR and perform submissions to Ethics Committees, Third Bodies and Regulatory Authorities as applicable Perform site contracts and budget negotiations Coordinate and track essential regulatory documents to ensure timely and compliant site activation and maintenance of site regulatory compliance throughout the study Support the CRA team in preparing for Site Initiation Visits to ensure timely distribution of clinical study supplies, accesses, and documents Perform remote visits as required by the monitoring plan Perform Case Review Form (CRF) review and monitoring of site proto...