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 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.
Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.
Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.