Site Navigator II

Paris - France

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

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 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 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.

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