Responsibilities

The FSP CRA (Level II) will conduct remote and on-site monitoring visits to investigational sites, assessing protocol and regulatory compliance, and managing required documentation. They will monitor investigator sites using a risk-based approach, applying root cause analysis and corrective actions to ensure site processes are in compliance. The role involves reviewing source data records (SDR), source data verification (SDV), and case report forms (CRF) to ensure data accuracy, documenting observations in reports and letters, and escalating deficiencies to clinical management. Additionally, the CRA will participate in investigator meetings, maintain regular contact with sites to confirm protocol adherence, and contribute to the investigator payment process, all while ensuring audit readiness and fostering collaborative relationships with investigational sites.