The Site Navigator II plays a key role in coordinating and managing site-level activities during the study start-up phase through maintenance and closeout. Acting as the primary liaison between investigative sites, sponsors, and internal teams, the role ensures regulatory compliance, efficient site activation, and consistent progress toward project milestones.
Coordinate and oversee activities from feasibility through activation extending through the maintenance phase of the study and closeout, ensuring compliance with ICH/GCP, local regulations, SOPs, and project timelines.
Act as the primary point of contact for investigative sites, managing site engagement, feasibility activities, and ongoing site support.
Identify, assess, and select suitable research sites, including conducting remote pre-study visits and managing supporting documentation.
Manage the collection, quality review, tracking, and maintenance of essential regulatory documents, ensuring ongoing site compliance.
Liaise with IRB/IEC, Regulatory Authorities, and third bodies as applicable, in collaboration with global regulatory teams
Perform initial contract and budget negotiations with the sites, as well as amended where applicable.
Support site initiation activities by coordinating with CRAs, vendors, and supply teams, and assisting with SIV preparation.
Perform remote visits as required by the monitoring plan including remote monitoring that may require SDV/SDR.
Track progress, proactively identify and escalate risks or issues, and ensure TMF accuracy and audit readiness at all times.
Experience Requested
The ideal candidate brings hands-on experience in clinical study start-up and regulatory processes, with the ability to manage multiple stakeholders and timelines in a regulated clinical research environment.
Minimum of 2+ years of experience in clinical development, study start-up, or regulatory processes.
Strong working knowledge of ICH/GCP, Regulatory Authority and IRB/IEC requirements, and investigator start-up documentation.
Demonstrated ability to manage multiple priorities and deadlines while ensuring regulatory and operational compliance.
Excellent communication, problem-solving, and negotiation skills, including experience supporting site contracts and budgets.
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