Responsibilities

The FSP CRA (Level II) will monitor investigator sites using a risk-based approach, applying root cause analysis and problem-solving skills to identify and resolve compliance issues. This role involves conducting on-site and remote visits to assess protocol and regulatory compliance, reviewing data, documenting observations in reports, escalating deficiencies, and maintaining regular contact with investigational sites. The CRA will also participate in investigator meetings, assist with investigator payments, and contribute to the resolution of issues and findings, ensuring audit readiness and adherence to SOPs.