About this role
We are looking for a clinical operations professional to join our team as a Site Navigator I 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 1-2 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.