SCRA - Korea - FSP Dedicatd

The Senior CRA will monitor investigator sites using a risk-based approach, applying root cause analysis and critical thinking to identify process failures and corrective actions. Responsibilities include ensuring data accuracy through SDR, SDV, and CRF review, assessing investigational product through physical inventory and records review, and documenting observations in reports and letters. The role involves escalating deficiencies to clinical management, maintaining contact with investigative sites, participating in investigator payment processes, and collaborating with team members on issue resolution. Additionally, the Senior CRA will identify potential investigators, initiate clinical trial sites to ensure compliance with protocol and regulatory obligations, perform trial close-out and retrieval of materials, and ensure essential documents are complete according to ICH-GCP and applicable regulations. They will also conduct on-site file reviews, provide trial status updates to the Clinical Team Manager, and ensure study systems are updated.