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.
Summary of Responsibilities:
Act as the primary point of contact for investigative sites during the start‑up phase
Conduct site outreach, feasibility and perform remote Pre-Study Visits
Perform country Participant Information Sheets/Informed Consent Forms adaptation to French requirements
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
Perform site contracts and budget negotiations
Coordinate and track essential regulatory documents to ensure timely and compliant site activation and 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
Qualifications (Minimum Required):
Qualifications (Minimum Required):
University degree (life sciences preferred)
Minimum 3 years’ experience in Clinical Operations and/or Start-Up
Knowledge of ICH/GCP, EU CTR and clinical trial processes
Fluent in English and French (written and spoken)
Strong 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.
Top Skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
