Junior Auditor

Preparing Study Audit Plan

• Develop audit plans for BA/BE and Phase I studies in consultation with senior personnel.

Conducting Study Audits

• Perform in-process and retrospective audits of Clinical and Statistical phases in consultation with senior personnel.

Preparation & Issuance of Audit Reports

• Prepare and issue audit reports (in-process and retrospective) for Clinical and Statistical phases with guidance and review from senior personnel.

Compliance Verification

• Assist seniors in verifying compliance of audit responses and ensure closure of audit reports.

Review of Study Reports

• Review draft and final study reports for accuracy and compliance.

Issuance of QA Authentication

• Issue QA authentication for studies as required.

Support in System Audits

• Assist auditors in conducting system audits.

• Support in Vendor Audits

• Assist auditors during vendor audits.

Support in Sponsor Audits

• Assist auditors during sponsor audits.

Trend Analysis Assistance

• Support auditors in performing trend analysis.

Document Control & Distribution

• Manage and distribute documents as and when required.

Other Assigned Tasks

• Perform any other tasks assigned by the auditor.