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Senior Clinical Research Auditor

1 month ago


Boston, Massachusetts, United States Piper Companies Full time

Piper Health and Sciences is seeking a seasoned professional to lead GCP audits and ensure regulatory compliance across clinical research phases.

The ideal candidate will plan and conduct internal and external audits, including system audits, supplier audits, and safety/pharmacovigilance audits.

This is a remote, full-time opportunity with travel requirements for in-person audit activities.

Key Responsibilities:
  • Perform GxP audits related to clinical research, including investigator site audits, TMF audits, CRF audits, and database audits.
  • Provide regulatory compliance advice 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 and ensure audits are delivered in accordance with clients' requirements and internal procedures.
  • Facilitate client audits and regulatory inspections.
Requirements:
  • 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 + bonus, depending on relevant years of industry experience.

Full comprehensive benefits package.