• Travel to site and monitor the clinical trial data generated at sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed.
• Take lead on study activities and perform co-monitoring visits with CRAs to support and guide them as per the requirements.
• Preparing site visit reports within timelines
• Ensure that site staff is qualified, experienced, and adequately trained to perform their role and responsibilities.
• Ensure study data collected is accurate and verifiable.
• Manage clinical trial site payments and handle any ongoing negotiations.
• Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study.
• Act as a mentor to site staff and provide continuous support and guidance as required.
• Ensure study documents are appropriately maintain in their respective files till archival
• Adheres to protocol, regulatory requirements, good clinical practice, and standard operating procedures.
• Assesses the trial site and applicable personnel on an ongoing basis.
• Ensures compliance with the patient-consent process and other study procedures.
• Verifies the receipt, handling, accounting, storage conditions, and availability of clinical trial material. Verifies compliance and quality of collected study data.
• Ensures compliance with the procedures to apply in the event of serious adverse events.
• Prepare an appropriate intervention plan to avoid redundant errors and deviations.
• Verifies investigator site files and ensure it is consistent with in-house files.
• Any other assigned task/activities as per the need of study and organization to be completed.

Work Experience

4-5 years of Monitoirng experience in Sponsor/ CRO setting

Education

Competencies