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
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
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