Job Responsibilities:
Conduct Site Initiation Visits (SIV), conduct Protocol, ICH-GCP and
SOP training at sites, demonstrate study procedures including Source
Templates Filing, Annotated CRFs & CRF filling instructions
(Paper/EDC), Informed Consent procedures, Patient Screening &
Eligibility procedures, IP Handling procedures, Safety Reporting &
Unblinding procedures etc. to investigators and CRCs, ensure timely SIV
reporting & follow-up letters
Conduct routine Site Monitoring Visits (SMV) to
clinical
sites, do Source Doc Verification, review Site Master Files (SMFs),
relevant study and patient records, resolve open site issues, ensure
timely SMV reporting and follow-up letters
Verify
Clinical Supplies Inventory and IP Management procedures at site and ensure complete and accurate drug accountability
Ensure Protocol Compliance in execution of trials, identify, document
and resolve protocol deviations and violations, informed consent
deviations and issue/action log
Ensure compliance to ICH-GCP, Indian GCP / Schedule Y and other applicable regulatory standards
Review communication of site with IRB/EC and other regulatory bodies
Act as Lead Monitor, maintain contact with site personnel and ensure
timely resolution for study specific queries as well as proper
escalation of site/project related issues to sponsor
Maintain audit readiness at the site level for any audits or regulatory inspections
Conduct site/study close-out activities and assure appropriate archival of controlled documents and retrieval of CRFs,
Clinical Supplies and other relevant study materials
Compile and review weekly and monthly project metrics relating to
study conduct e.g. Patient Screening, Recruitment & Drop-outs,
Subject Logs, Safety Logs, CRF Retrieval status etc.
Manage and provide oversight to New Study Feasibilities including site feasibilities and qualification
