1) Conduct and Update Training activities according to the training schedule requirement from time to time.
2) Prepare Training Schedule, coordinate with the trainees and trainer, conduct the training, evaluate and maintain the training records and Update Curriculum Vitae(CV) of all clinical and Contract personnel
3) Provide Induction and ongoing training to department personnel
4) Inspecting and review clinical study activities online to ensure compliance to SOPs and Good clinical Practices (GCP) and Good Laboratory Practices (GLP)
5) Prepare Update and Maintain Calibration, maintenance and Performance check schedule online to ensure compliance to SOPs and Good Clinical Practices (GCP).
6) Perform the Periodic review(s)of the facility and system .Report the finding of the same to Head CR
7) Coordinate with QA department for issue of documents like SOPs, Forms,Formats,Log Book, Protocol, CRF and ICF according to requirement
This shall include the following:
– Review the draft ICF (Both Marathi and English)
– Review the draft Protocol,CRF and Report
– Review the draft SOPs
8) Keep the accountability of Logbooks used in the laboratory and also archival of the same
– Review the Project specific Raw data for accuracy, completeness and internal consistency and compliance to SOPs, Protocol,ICFs and CRF
– Review of medical screening records and ICFs for study
– Compliance of essential documents before/during/ after study
– Compliance of Project Reports
– Subject withdrawal or drop-out data, Investigational Product related records
– Sample transfer from clinical to bioanalytical laboratories
9) Review reports generated during the study period against the raw data and ensure that the reports accurately reflect the same and make necessary corrections through the concerned personnel.
10) Ensure that corrective actions have been implemented and preventive measures have been taken to the findings of the review. Verification and review of corrective actions and preventive measures have been taken during follow-up.
11) Update the summary of the projects compliance status from time to time to Head, CR
12) Assist the Project Manager in ensuring that corrective actions have been made to Quality Assurance audits reports.
13) Review the raw data after the corrections for their completeness and correctness and forward the relevant data to the QA department.
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