GCP Auditor (Hematology)

Piper Companies is seeking a GCP Auditor Consultant to join a clinical-stage biopharmaceutical company specialized in developing gene-edited cell therapies, particularly CAR T-cell candidates, aimed at treating various cancers and other serious diseases.

The ideal GCP Auditor Consultant will have a background in hematology, as well as experience in a clinical trial setting. This is a remote role based out of Raleigh, NC and does require international travel.

Responsibilities of the GCP Auditor Consultant:

• Conduct clinical site audits and internal reviews to ensure compliance with GCP standards and protocol requirements.
• Evaluate trial documentation, patient data, and medical justifications related to protocol deviations.
• Collaborate with cross-functional clinical leadership to support trial oversight and quality assurance.
• Travel to domestic and international trial sites for short-term audit visits, with flexible scheduling based on site readiness.
• Prepare audit findings and reports for internal stakeholders, contributing to continuous improvement of clinical operations.
• Engage with senior clinical leadership throughout the audit process, supporting strategic decision-making and trial integrity.

Qualifications for the GCP Auditor Consultant:

• 5+ years of experience in clinical trials, with a strong preference for candidates with exposure to cell therapy.
• Active involvement in the hematology/oncology field, with up-to-date knowledge of current treatment landscapes.
• Prior GCP audit experience preferred; recent hands-on involvement is highly valued.
• Medical background not required to be an MD; RN, PA, or pharmacy degree strongly preferred.
• Proven ability to identify protocol deviations and evaluate medical justifications effectively.
• Familiarity with AMPT and recombinant medicine standards, and a solid understanding of blood cancers and associated therapies.

Compensation for the GCP Auditor Consultant:

• Salary Range: $145/hr - $165/hr dependent on experience
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 9/12/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: GCP auditing, GCP auditor, GCP compliance auditor, clinical trial auditor, GCP audit consultant, good clinical practice, clinical trials, cell therapy, CAR-T, hematology, oncology, protocol deviations, medical justification, patient data review, chemotherapy, immunotherapy, bone marrow recovery, clinical operations, audit reporting, cross-functional collaboration, AMPT standards, recombinant medicine, blood cancer, RN, PA, site audits, international travel, trial oversight, quality assurance, stakeholder engagement

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