Site Navigator - Remote US & Canada

Job Overview
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 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.

Job Overview
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 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.

• 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 Study Participant 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 collection of feasibility survey
• Apply independent judgment and discretion in managing site-level activities, resolving issues, and making decisions that support study timelines and compliance requirements.
• 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 compliant study site activation from site outreach, submissions, greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting annual IRB/Independent Ethics Committee (IEC) renewals, PI changes, and document expirations will be performed as applicable in compliance with local requirements.
• 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 elevate issues in a timely manner
• Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance
• Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead (GRSL)
• Perform initial contract and budget negotiations with the sites, as well as amended where applicable.
• Ensure high quality…