Piper Companies
GCP Auditor - Hematology-Oncology, CAR-T Therapies
Piper Companies, Cary, North Carolina, United States, 27518
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. 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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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. 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
#J-18808-Ljbffr