12 ago
|
Fortrea
|
Ciudad de México
12 ago
Fortrea
Ciudad de México
Job Overview:
Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Senior Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
The Senior Site Navigator serves as local country expert in study start-up activities for a particular country or region. As senior team members, they perform work with limited oversight and their responsibilities include acting as a “knowledge resource,” mentoring /training junior colleagues if suitable.
The Senior Site Navigator proactively anticipates and mitigates issues that could delay the study.
Summary of Responsibilities:
- Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights, wellbeing and safety are protected
- Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources.
- Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
- Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor, protocol, local and country regulations and requirements
- Support
📌 Sr. Site Navigator (Ciudad de México)
🏢 Fortrea
📍 Ciudad de México