Clinical QC professional

• Review of pre-study file, during study and post study files, vaccutainer/vial labels, log books, completed ICF and CRFs in timely manner

• Ensuring that all staff involved in the study is trained in protocol

• Ensure that all the activities are been done as per protocol ,SOP s and GCP

• Assessing in pharmacy related activities (like Acceptance, labeling, dispensing, reconciliation and storage of IP s)

• Online monitoring and taking print of the temperature record from the software

• Providing study related information to the Ethics Committee, Contracted hospitals and Insurance company

• Preparation of study up- after completion of the study and send it to technical Documentation

• Preparation of Statistical up- and send it to the respective person

• Review clinical report

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