Clinical Trials - QA

2 - 6 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for planning and conducting investigator site selection audits and clinical trial study audits at investigator sites following the applicable GCP guidelines and regulations. Your duties will include reviewing subject ICF and medical records, CRF design, and standard operating procedures. You will need to issue audit reports to the investigator site staff and other study personnel and review and assess audit responses/CAPA for timely closure of audit reports. Additionally, you will be required to provide regular updates on non-compliance or major findings in clinical trials to the Head of Quality Assurance, review Clinical study reports, and offer document review comments in a timely manner.,

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