Job Overview:
Site Navigators II plays 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 Site Navigator II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
This role serves as a local expert in project start-up/clinical activities for a particular country or region, performs work with limited oversight, and acts as a ‘knowledge resource’ to mentor and train junior colleagues if suitable.
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 customization and translation of informed consent forms and patient-facing materials.

Collect, track and perform a quality review of all essential documents required for effective and comp...

📌 Site Navigator II (Buenos Aires)
🏢 Fortrea
📍 Buenos Aires