Site Navigator Site Readiness

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 startup 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 inspectionready

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