Auditor

Position :

Department :

Location :

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.
• Plan & conduct system/Internal audits of clinical research processes, procedures, and systems to ensure compliance with applicable regulatory requirements, industry standards, and client expectations.
• Plan and conduct vendor audit to ensure compliance with study and/or Sponsor requirements and applicable regulatory requirements.
• Responsible for overviewing the internal QA processes.

Qualifications & experience required

• 3 to 6 Years of experience as a Clinical QA for a CRO.
• Experience in auditing CT, PK-stats & DM processes & clinical software's like eTMF, CTMS & rSDV.