Responsibilities

The FSP CRA (Level I/II) will monitor investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions to bring the site into compliance and decrease risks. This role involves ensuring data accuracy through SDR, SDV, and CRF review, conducting on-site and remote monitoring activities, assessing investigational product through physical inventory and records review, documenting observations in reports and letters, bringing up observed deficiencies to clinical management, and following issues through to resolution. The CRA will also maintain regular contact with investigative sites, conduct monitoring tasks in accordance with the approved monitoring plan, participate in the investigator payment process, ensure a shared responsibility for issue resolution, investigate and follow up on findings, and participate in investigator meetings. Additionally, the CRA may assist in identifying potential investigators, initiate clinical trial sites, perform trial close out, and retrieve trial materials.