Clinician to CRA - UK, FSP

Perform and coordinate various aspects of the clinical monitoring and site management process. Conduct remote or on-site visits to assess protocol and regulatory compliance, managing all required documentation. Ensure adherence to sponsor and monitoring environment procedures and guidelines, acting as a site processes specialist to guarantee subject rights, well-being, and data reliability in accordance with the approved protocol, ICH-GCP guidelines, and applicable regulations. Maintain audit readiness and develop collaborative relationships with investigational sites. Monitor investigator sites using a risk-based approach, applying root cause analysis to identify and resolve site process failures. Ensure data accuracy through SDR, SDV, and CRF review, assessing investigational product inventory and records. Document observations in reports and letters promptly, escalating deficiencies and issues to clinical management for resolution. Maintain contact with investigative sites to confirm protocol adherence and issue resolution, conducting monitoring tasks per the approved plan. Participate in the investigator payment process and collaborate with project team members on issue resolution. Participate in investigator meetings and assist in identifying potential investigators.