About the Job

Site management responsibility for clinical studies .

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

client data management systems.
• Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are

complete and current throughout the duration of the trial.
• Guarantees that the study Investigational Product inventory and accountability is accurate

and that study materials are stored securely and per protocol requirements.
• Ensures adherence to global quality control and CRA performance metrics.
• Ensures audit readiness at site level.
• Acts in the project role of a Lead CRA as assigned.

Requirements for this position are :

Qualifications (Minimum Required):
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements

Experience (Minimum Required):
• A minimum of 2 years of Clinical Monitoring experience.