Site Navigator - Site Readiness

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.