Chargement en cours

Site Navigator - Site Readiness

PARIS, 75
il y a 1 jour

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 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

Learn more about our EEO & Accommodations request here.

#J-18808-Ljbffr
Entreprise
Fortrea
Plateforme de publication
WHATJOBS
Offres pouvant vous intéresser
Soyez le premier à postuler aux nouvelles offres
Soyez le premier à postuler aux nouvelles offres
Créez gratuitement et simplement une alerte pour être averti de l’ajout de nouvelles offres correspondant à vos attentes.
* Champs obligatoires
Ex: boulanger, comptable ou infirmière
Alerte crée avec succès