Clinical Auditor
Piper Companies is seeking a Senior GCP (Clinical) Auditor / Compliance Specialist to support Quality Assurance activities for a clinical research organization. This is a full‑time, 100% remote position with approximately 15–20% domestic and international travel for clinical site audits. The ideal candidate is experienced in independently leading GCP audits and excels in a fast‑paced, collaborative environment while ensuring regulatory compliance across clinical trial operations.
Note: Candidates must have independently led GCP audits in a clinical environment. Experience limited to audit participation, audit readiness, or GLP‑only audits will not be considered. Candidates must live in Delaware, Maryland, Virginia or North Carolina during employment.
Responsibilities of the Senior GCP Auditor / Compliance Specialist:
• Lead independent GCP audits of clinical trial sites to ensure compliance with regulatory requirements and industry standards.
• Support the development, implementation, and maintenance of the Quality Management System (QMS).
• Oversee key QA functions including training, document control, CAPA management, and complaint handling.
• Conduct internal audits and drive continuous improvement through quality metrics and performance monitoring.
• Review, update, and maintain QA‑controlled documentation to ensure alignment with current procedures and regulations.
• Support vendor and supplier audits and assist during regulatory inspections.
Qualifications of the Senior GCP Auditor / Compliance Specialist:
• Bachelor’s degree required.
• Proven experience independently leading GCP audits in a clinical research environment (GCP experience required; GMP/GLP‑only experience not sufficient).
• Strong understanding of GCP regulations, regulatory audit processes, and quality systems within CRO environments.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.
Compensation of the Senior GCP Auditor / Compliance Specialist:
• Salary Range: $80,000 – $110,000 per year, based on experience and certifications (open to associate‑ and specialist‑level candidates).
• Benefits: Comprehensive benefits package including Cigna Medical, Dental, Vision, and 401(k) through ADP.
This job opens for applications on 03/16/2026. Applications will be accepted for at least 30 days from the posting date.
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Note: Candidates must have independently led GCP audits in a clinical environment. Experience limited to audit participation, audit readiness, or GLP‑only audits will not be considered. Candidates must live in Delaware, Maryland, Virginia or North Carolina during employment.
Responsibilities of the Senior GCP Auditor / Compliance Specialist:
• Lead independent GCP audits of clinical trial sites to ensure compliance with regulatory requirements and industry standards.
• Support the development, implementation, and maintenance of the Quality Management System (QMS).
• Oversee key QA functions including training, document control, CAPA management, and complaint handling.
• Conduct internal audits and drive continuous improvement through quality metrics and performance monitoring.
• Review, update, and maintain QA‑controlled documentation to ensure alignment with current procedures and regulations.
• Support vendor and supplier audits and assist during regulatory inspections.
Qualifications of the Senior GCP Auditor / Compliance Specialist:
• Bachelor’s degree required.
• Proven experience independently leading GCP audits in a clinical research environment (GCP experience required; GMP/GLP‑only experience not sufficient).
• Strong understanding of GCP regulations, regulatory audit processes, and quality systems within CRO environments.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications.
Compensation of the Senior GCP Auditor / Compliance Specialist:
• Salary Range: $80,000 – $110,000 per year, based on experience and certifications (open to associate‑ and specialist‑level candidates).
• Benefits: Comprehensive benefits package including Cigna Medical, Dental, Vision, and 401(k) through ADP.
This job opens for applications on 03/16/2026. Applications will be accepted for at least 30 days from the posting date.
Apply tot his job
Apply To this Job