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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
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