[Remote] FSP CRAII at Thermo Fisher Scientific

The FSP CRAII role requires performance and coordination of clinical monitoring and site management processes, including remote or on-site visits to assess protocol and regulatory compliance. The role involves managing documentation and procedures from various sponsors, acting as a site processes specialist to ensure adherence to protocols, ICH-GCP guidelines, and applicable regulations. A risk-based monitoring approach is necessary, utilizing root cause analysis, critical thinking, and problem-solving skills to identify and rectify site process failures. The role also includes ensuring data accuracy through SDR, SDV, and CRF review, assessing investigational product, documenting observations, escalating deficiencies, and maintaining communication with investigative sites. Responsibilities extend to participating in the investigator payment process, resolving findings, participating in investigator meetings, identifying potential investigators, initiating clinical trial sites, performing trial close-out activities, ensuring crucial document completeness, conducting on-site file reviews, providing trial status updates, updating study systems, and facilitating communication between sites, clients, and project teams.