Site Navigator II

<div><p><span>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.</span></p><p></p><p><span class="emphasis-2"><b>Summary of Responsibilities:</b></span></p><ul><li><p><span>Act as the primary point of contact for investigative sites during the start‑up phase</span></p></li><li><p><span>Conduct site outreach, feasibility and perform remote Pre-Study Visits</span></p></li><li><p><span>Perform country Participant Information Sheets/Informed Consent Forms adaptation to French requirements</span></p></li><li><p><span>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</span></p></li><li><p><span>Perform site contracts and budget negotiations</span></p></li><li><p><span>Coordinate and track essential regulatory documents to ensure timely and compliant site activation and maintenance of site regulatory compliance throughout the study</span></p></li><li><p><span>Support the CRA team in preparing for Site Initiation Visits to ensure timely distribution of clinical study supplies, accesses, and documents</span></p></li><li><p><span>Perform remote visits as required by the monitoring plan</span></p></li><li><p><span>Perform Case Review Form (CRF) review and monitoring of site protocol deviations and Serious Adverse Event (SAE) reporting</span></p></li><li><p><span>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 </span></p></li><li><p><span>Maintain accurate documentation in study systems and ensure the TMF is inspection‑ready</span></p></li></ul></div><p></p><p><span class="emphasis-2"><b>Qualifications (Minimum Required): </b></span></p><ul><li><p><span>Qualifications (Minimum Required): </span></p></li><li><p><span>University degree (life sciences preferred)</span></p></li><li><p><span>Minimum 3 years’ experience in Clinical Operations and/or Start-Up</span></p></li><li><p><span>Knowledge of ICH/GCP, EU CTR and clinical trial processes</span></p></li><li><p><span>Fluent in English and French (written and spoken)</span></p></li><li><p><span>Strong organizational skills, attention to detail, and willingness to learn</span></p></li><li><p><span>Ability to manage multiple tasks in a structured and proactive way</span></p></li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO &amp; Accommodations request here</a><span>.</span></p>