Senior Clinical Research Auditor

13 hours ago


Boston, Massachusetts, United States Piper Companies Full time
Senior GCP Auditor Job Description

Piper Health and Sciences is seeking a seasoned Senior GCP Auditor to lead internal and external audits, ensuring compliance with GCP regulations across all phases of clinical research.

Key Responsibilities:
  • Conduct GxP audits, including investigator site audits, TMF audits, CRF audits, database audits, and for-cause audits.
  • Provide regulatory compliance guidance to internal and external partners on GxP and safety/PV requirements.
  • Review and gather responses to audit observations, escalating priority responses to ensure timely resolution.
  • Engage in client meetings, ensuring audits meet client requirements and internal procedures.
  • Facilitate client audits and regulatory inspections.
Requirements:
  • 5-9 years of experience in quality assurance, regulatory, and/or auditing related to clinical research.
  • Understanding of national and international laws related to clinical trials.
  • Experience conducting internal and external GCP audits.
  • Ability to travel up to 60%.
Compensation:
  • $110,000 - $150,000 base salary + bonus, depending on relevant industry experience.
  • Full comprehensive benefits package.


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