Site Navigator II
3 days ago
Rueil-Malmaison
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 protocol deviations and Serious Adverse Event (SAE) reporting, • Actively participate in study team meetings to support study progress, develop and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and escalate issues in a timely manner, • Maintain accurate documentation in study systems and ensure the TMF is inspection‑ready Qualifications (Minimum Required): • University degree (life sciences preferred), • Minimum 3 years’ experience in Clinical Operations and/or Start-Up, • Knowledge of ICH/GCP, EU CTR and clinical trial processes, • Fluent in English and French (written and spoken), • Strong organizational skills, attention to detail, and willingness to learn, • Ability to manage multiple tasks in a structured and proactive way