FSP CRA II

The FSP CRA II will monitor investigator sites using a risk-based approach, performing root cause analysis to identify and correct compliance issues and decrease risks. Responsibilities include ensuring data accuracy through site monitoring and records review, assessing investigational product, and documenting observations in timely reports. The role involves escalating deficiencies to management, maintaining contact with sites to confirm protocol adherence and issue resolution, and conducting monitoring tasks according to the approved plan. Additionally, the CRA II will participate in investigator payments and issue resolution with project team members, identify potential investigators, initiate clinical trial sites, and perform trial close-out activities. Ensuring essential documents are complete and compliant with ICH-GCP and regulations, conducting on-site file reviews, and providing study status updates to the Clinical Team Manager are key duties. The position also requires facilitating communication between sites, clients, and project teams, responding to regulatory requirements and audits, and completing administrative tasks. Contributing to project publications, tools, and process improvement initiatives is also expected.