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:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
• Minimum 5 years of experience in clinical research auditing, with a strong background in hematology-oncology 
  • Preferred experience with advanced therapy medicinal products (ATMPs).
• Proven experience in protocol review and risk-based quality assessment.
• Deep understanding of ICH-GCP, FDA, and EMA regulations.
• Excellent analytical, communication, and report-writing skills.
• Willingness to travel up to 50% internationally.
• and preventive actions (CAPAs).

1099 Assignment

• $175 - $225/hr
  • Travel time is compensated at 50%
  • Travel expenses covered within compliance of corporate travel policy guidelines
• Available to consultants working concurrent projects
  • Site Visits will require 40 hours/week
  • All other work can be completed remotely