GCP Auditor

2 weeks ago

Cary, NC, United States Piper Companies Full time
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

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