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).