GCP Auditor - Hematology-Oncology, CAR-T Therapies

Job Summary :

We are seeking an experienced GCP Auditor to support global clinical trials involving CAR-T cell therapies in hematology-oncology. This role goes beyond standard GCP compliance auditing — it includes a critical evaluation of the scientific and operational robustness of clinical trial protocols, ensuring they are fit for purpose, ethically sound, and capable of generating high-quality data across diverse regulatory environments in the US and EU.

Key Responsibilities :

• Conduct comprehensive audits of investigator sites, and internal processes to assess compliance with ICH-GCP, FDA, EMA, and other applicable regulations.
• Evaluate the design, feasibility, and operational integrity of clinical trial protocols for CAR-T therapies.
• Identify gaps or weaknesses in protocol implementation that could impact patient safety, data integrity, or regulatory compliance.
• Provide strategic feedback on protocol structure, endpoints, inclusion / exclusion criteria, and risk mitigation strategies.
• Document audit findings and collaborate with cross-functional teams to make suggestions for corrective and preventive actions (CAPAs).

Qualifications :

1099 Assignment