Site Navigator

Fortrea; Rueil-Malmaison; Sur place; EUR 36 000 - 48 000; Plein temps

Résumé du poste

Fortrea in France seeks a motivated Site Navigator I to act as the primary contact for investigative sites, coordinating outreach, feasibility, and remote pre-study visits.

The role supports CRA teams, reviews essential study documents, and ensures regulatory compliance across site activities, with strong English and French communication for cross-border collaboration.

Qualifications

• 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.

Responsabilités

• 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 elevate 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

Connaissances

Effective communication

Organizational skills

Attention to detail

Multitasking

Bilingual English/French

Formation

University degree (life sciences preferred)

Description du poste

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 elevate 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