Senior Clinical Quality Assurance Auditor

Translational Research in Oncology; New York (NY); Remote; USD 80,000 - 110,000; Full time

Job summary

Translational Research in Oncology is seeking a Senior Clinical Quality Assurance Auditor to join their remote Quality Assurance team. The role involves conducting audits, ensuring compliance with regulations, and fostering a culture of quality. Candidates should have extensive experience in clinical quality assurance and a strong understanding of clinical trial processes. TRIO offers a competitive salary and comprehensive benefits.

Benefits

Health Plans

401(k)

Paid Time Off

Flexible Hours

Remote Work

Qualifications

• Minimum 5 years experience in clinical quality assurance, including audits and inspections.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.

Responsibilities

• Conduct audits of clinical trials to assess compliance with regulations.
• Develop and maintain audit plans and ensure documentation of findings.
• Provide training on quality assurance practices and regulations.

Skills

Analytical Skills

Problem-Solving

Leadership

Communication

Education

Bachelor's degree in life sciences

Master’s or Ph.D.

Tools

Word

Excel

PowerPoint

Job description

If you are an experienced Senior Clinical Quality Assurance Auditor (internally referred to as Senior Clinical Quality Assurance Manager) who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

Responsibilities

Clinical Quality Assurance Auditor (internally referred to as Senior Clinical Quality Assurance Manager) to join our Quality Assurance team. Reporting to the Senior Director of Quality Assurance, this position will be remote-based in the United States. Responsibilities include:

1. Conduct Audits: Plan and execute comprehensive audits of clinical trials, including clinical trial master files, internal processes, investigator sites, CROs, and other relevant entities to assess compliance with regulations, guidelines, and SOPs.
2. Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections, supporting preparation, conduct, and response development (CAPA).
3. Quality Assurance Documentation: Develop and maintain audit plans, reports, inspection readiness plans, and ensure accurate documentation of findings and corrective actions.
4. Training and Education: Provide training on quality assurance practices, regulations, and standards, fostering a culture of quality and compliance.
5. Quality Management System: Support the development and maintenance of the organization’s QMS, including SOP revisions and metrics analysis.
6. Process Improvement: Collaborate on identifying process improvements and implementing best practices for clinical quality systems.
7. Regulatory Compliance: Stay updated on regulations, interpret and communicate requirements to ensure compliance.
8. Risk Assessment: Conduct risk assessments, develop mitigation strategies, and ensure controls are in place.
9. Collaboration and Communication: Maintain strong relationships with internal teams and external partners to facilitate audits, inspections, and submissions.

Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, or related field; Master’s or Ph.D. preferred.
• Minimum 5 years (8 preferred) experience in clinical quality assurance, including audits and inspections in pharma, biotech, or CRO settings.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.
• Strong understanding of clinical trial processes.
• Excellent analytical, problem-solving, leadership, and communication skills.
• Relevant certifications (e.g., CQA, CCRP) are highly desirable.
• Knowledge of risk-based quality management principles.
• Fluent English, proficient in Word, Excel, PowerPoint.
• Willingness to travel internationally as needed.

What TRIO Can Offer You

• Competitive salary range: $80,000 - $110,000, influenced by experience and qualifications.
• Comprehensive benefits including health plans, 401(k), paid time off, flexible hours, remote work, and more.
• Opportunities for professional growth and development.

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