Responsibilities

The FSP CRA (Level II) will monitor investigator sites using a risk-based approach, conducting remote or on-site visits to assess protocol and regulatory compliance, and managing required documentation. This 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, escalating deficiencies to clinical management, and maintaining regular contact with investigational sites. The position also includes participating in investigator meetings, assisting with the investigator payment process, and contributing to the resolution of issues and findings, as well as ensuring audit readiness and developing collaborative relationships with investigational sites.