CRA (Level II)

The CRA (Level II) is responsible for monitoring investigator sites to ensure protocol and regulatory compliance, managing documentation, and guaranteeing subject rights, well-being, and data reliability. They will assess investigational products, document observations, and escalate deficiencies to clinical management for resolution. Responsibilities include maintaining contact with investigative sites, conducting monitoring tasks according to the approved plan, participating in the investigator payment process, and collaborating with team members on issue resolution. The CRA will also participate in investigator meetings, identify potential investigators, initiate clinical trial sites, perform trial close out, ensure essential documents are complete, conduct on-site file reviews, and provide trial status reports to the Clinical Team Manager.