Key Responsibilities

- Plan & conduct the Study audits as per audit plan in compliance with internal procedures, protocol and applicable regulatory requirements
- Plan and conduct Investigator site audit, file/document audit for Clinical Trial Projects to ensure compliance with SOPs, Protocol, ICH GCP, quality system and applicable regulatory requirements.
- Review study documents like Protocol, Study plans, Informed Consent Document, Case Report Form, Clinical Study Report, Data Management etc. to ensure compliance, correctness and adequacy with ICH GCP and other applicable regulatory requirements
- Assist in facilitating the sponsor and regulatory audits.
- Review of final study reports.
- Assist in system/Internal audits of clinical research processes, procedures, and systems to ensure compliance with applicable regulatory requirements, industry standards, and client expectations.
- Assist in vendor audit to ensure compliance with study and/or Sponsor requirements and applicable regulatory requirements.
- Ensure the controlling and distribution and QA documents archiving activities

Qualifications & experience required

- Minimum of 3 to 5 Years of Clinical QA experience.
- Pharma/LifeSciences - Graduates/Postgraduates

📌 Junior Auditor (Ahmedabad)
🏢 COD Research
📍 Ahmedabad