cra ii

Summary of Responsibilities:

• Site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.
• Conducts site monitoring responsibilities for clinical trials according to Fortrea's Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
• Prepares and implements project plans related to Clinical Monitoring responsibilities.
• Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.
• Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or cl...