Job description

ORGANISATIONAL OVERVIEW

JOB DETAILS

• Attend and facilitate Investigators Meeting.
• Training of Investigators on Protocol and other applicable regulatory guidelines.
• Perform Site visits (i.e. Site Selection Visit, Site Initiation Visits, Site monitoring visits and site close-out visits) in accordance with the protocol and other applicable regulatory guidelines.
• Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities
• Ensure compliance of all study-related requirements and its documents/data.
• Coordinate and distribute Clinical Study Materials to study sites
• Ensure calibration of all equipment to be used for the study.
• Act as a communication Link between LTR team and the site
• Maintain accurate and timely sponsor/site correspondence and communication
• Maintain updated Site Files and collection of project related documents during the site visits and maintain Site Master file
• CRF retrieval/ e-CRF review as per the project management plan and project manager instructions
• Archival of study documents in a timely manner at sites or at third party archival facility as per prevailing SOPs and project management plan.
• Any other responsibilities as assigned by the Supervisor/HOD/Management.

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