FSP CRA (Level II)

The FSP CRA (Level II) will perform and coordinate various aspects of clinical monitoring and site management, including conducting remote or on-site visits to assess protocol and regulatory compliance. They will manage required documentation, ensure adherence to sponsor and supervising environment guidelines, and act as a site processes specialist to guarantee trial compliance with the protocol, ICH-GCP guidelines, and applicable regulations. Key responsibilities include applying risk-based monitoring, performing root cause analysis, critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions. The role entails ensuring data accuracy through SDR, SDV, and CRF review, assessing investigational product through physical inventory and records review, and documenting observations in reports and letters promptly. They will escalate observed deficiencies and issues to clinical management and follow them through to resolution, potentially maintaining regular contact with investigative sites. The CRA will conduct supervising tasks per the monitoring plan, participate in the investigator payment process, and ensure shared responsibility for issue resolution. Additionally, they will investigate and follow up on findings, participate in investigator meetings, identify potential investigators, initiate clinical trial sites, perform trial close-out, and retrieve trial materials. The role also includes ensuring required crucial documents are complete, conducting on-site file reviews, providing trial status tracking and progress update reports, ensuring study systems are updated, and facilitating effective communication between investigative sites, the client company, and the PPD project team.