Senior Clinical Research Auditor

1 week ago


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

Piper Health and Sciences is seeking a Senior GCP Auditor to plan and conduct internal and external audits, including system audits, supplier audits, safety/pharmacovigilance (PV) audits, and others. This is a remote, full-time opportunity with travel requirements for in-person audit activities.

Responsibilities:
  • Perform GxP audits related to clinical research, including investigator site audits, TMF audits, CRF audits, database audits, for-cause audits, supplier audits, regulatory inspections, and others.
  • Provide advice on regulatory compliance to internal and external partners regarding implementation of GxP and safety/PV requirements.
  • Review and gather responses to audit observations and escalate priority responses to ensure timelines are met.
  • Engage in client meetings and ensure audits are delivered in accordance with clients' requirements and internal procedures.
  • Facilitate client audits and regulatory inspections.
Qualifications:
  • 5-9 years of experience in quality assurance, regulatory, and/or auditing as it relates 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 + bonus, depending on relevant years of industry experience.
  • Full comprehensive benefits package.


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