Site Navigator - Site Readiness

ftfra fortrea france sarl

📍 paris france🕐 1mo ago🔗 workday

Job Description

Ready to take the next step in your clinical research career? We are seeking a motivated Clinical Operations professional to join our team as a Site Navigator I. This role offers the opportunity to gain valuable experience, collaborate with global teams, and grow within a leading CRO. **Summary of Responsibilities:** * Act as the primary point of contact for investigative sites throughout the course of the study * Conduct site outreach, feasibility and perform remote Pre-Study Visits * Collect, track, and perform a quality review of all essential documents required for the site activation and for the 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 * Perform country and site Participant Information Sheets/Informed Consent Forms review/customization as applicable * Manage country and site level documents for Part II submission under EU CTR or for Ethics Committees, Third Bodies and Regulatory Authorities as applicable * Perform site contracts and budget negotiations as applicable **Qualifications (Minimum Required):** * University degree (life sciences preferred) * 1-2 years’ experience in Clinical Operations and/or Start-Up * Knowledge of ICH/GCP, EU CTR and clinical trial processes/regulations * Effective communication * Fluent in English and French (written and spoken) * Organizational skills, attention to detail, and willingness to learn * Ability to manage multiple tasks in a structured and proactive way Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).
Site Navigator - Site Readiness at ftfra fortrea france sarl | MergeJobs