Job Overview:

We are seeking an experienced GCP Auditor to join our Quality Assurance team. The ideal candidate will have a strong working knowledge of clinical trial operations, including familiarity with ICH E6 (R2 and R3) guidelines, FDA CFR Part 312, Part 50, Part 54, and Part 56. The role involves overseeing and managing audits of clinical sites, clinical vendors, and ensuring compliance with Good Clinical Practice (GCP) standards in oncology studies ranging from Phase 1 to Phase 3.

Key Responsibilities:

Auditing & Compliance:
Oversee and conduct GCP audits of clinical sites, ensuring adherence to regulatory requirements and internal SOPs.
Manage and perform audits of clinical vendors, including Clinical CROs, central imaging services, and central laboratories.
Review and respond to findings, ensuring corrective actions are implemented and followed up as necessary.
Clinical Trial Oversight:
Provide guidance and support to study teams on GCP-related issues, dedicating over 50% of time to addressing questions and providing expert advice.
Collaborate with study teams to ensure ongoing compliance throughout the study lifecycle, from Phase 1 through Phase 3 oncology trials.
Ensure robust oversight of outsourced study management operations, particularly with Clinical CROs.
Vendor Management:
Assist in managing and resolving issues with clinical vendors, ensuring they meet quality standards and regulatory requirements.
Work closely with vendors to ensure the integrity of data collected, especially in critical areas such as oncology imaging and laboratory services.
Quality Assurance & Improvement:
Contribute to the continuous improvement of QA processes, including the development and implementation of best practices.
Maintain up-to-date knowledge of regulatory requirements and industry best practices, particularly in the areas of GCP and oncology clinical trials.

Qualifications:

Strong familiarity, and ideally working knowledge, of ICH E6 R2, R3, and FDA CFR Part 312, Part 50, Part 54, Part 56.
Extensive experience in clinical trial operations, particularly through roles such as Clinical Research Associate (CRA), Study Manager, or Study Coordinator.
Significant experience in overseeing and managing GCP audits, particularly in Phase 1-3 oncology studies.
Strong understanding of clinical vendor management, with experience in auditing Clinical CROs, central imaging services, and central laboratories.
Experience in QA or compliance roles within clinical research, with a focus on ensuring regulatory compliance and improving QA processes.
Excellent communication and interpersonal skills, with the ability to provide clear guidance and support to study teams.

Preferred Qualifications:

Bachelor’s degree in a related field such as Life Sciences, Nursing, or Quality Management.
Professional certification in Quality Assurance or Clinical Research (e.g., CQA, CCRP).
Experience in oncology clinical trials and familiarity with the unique challenges and requirements of these studies.

Benefits:

Competitive salary and comprehensive benefits package.
Opportunities for professional growth and development.
Work with a dynamic team dedicated to advancing clinical research and ensuring the highest standards of quality and compliance.

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