Act as the primary point of contact for investigative sites across start‑up, activation, and monitoring phases
Coordinate site‑level activities from feasibility and outreach through site activation and ongoing maintenance
Conduct remote and on‑site monitoring visits, including routine, initiation, and close‑out visits
Ensure compliance with ICH/GCP, local regulations, SOPs, and protocol requirements
Manage regulatory submissions, IRB/IEC interactions, essential documents, and TMF quality
Verify informed consent processes and ensure patient rights, safety, and wellbeing are protected
Perform source data review, CRF review, query resolution, and data validation
Track site performance, risks, and timelines, escalating issues proactively
Support contract and budget negotiations with investigative sites
Collaborate closely with CRAs, project managers, sponsors, vendors, and internal stakeholders
Maintain audit‑ready sites and documentation at all times
