Job Description

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.

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