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
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.
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.
- Mumbai India, New Delhi
- Full time
- Job requisition ID 2414724