Senior Clinical Quality Assurance Auditor

TRIO - Translational Research in Oncology; Washington (District of Columbia); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading organization in oncology research seeks a Senior Clinical Quality Assurance Auditor to ensure compliance in clinical trials. The role involves conducting audits, training, and supporting quality management systems. This remote position offers competitive compensation and benefits.

Benefits

Competitive compensation

Vacation and paid holidays

Comprehensive health/medical plans

Retirement plan with up to 5% match

Flexible hours and remote work options

Home office stipend

International work opportunities

Employee assistance programs

Qualifications

• 5+ years of clinical quality assurance experience.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.

Responsibilities

• Conduct audits of clinical trials and internal processes.
• Assist in hosting Sponsor audits and Regulatory Authority inspections.
• Develop and maintain audit plans and documentation.

Skills

Analytical Skills

Problem-Solving

Leadership

Communication

Attention to Detail

Education

Bachelor's degree in life sciences

Higher degrees

Tools

Word

Excel

PowerPoint

Job description

Senior Clinical Quality Assurance Auditor

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 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.

TRIO is seeking a Senior 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

1. Conduct Audits: Plan and execute comprehensive audits of clinical trials, including auditing clinical trial master files, internal processes, investigator sites, CROs, and other entities to ensure compliance with regulations, guidelines, and SOPs.
2. Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections, including preparation, conduct, and developing responses to findings.
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 QMS, including procedures and metrics analysis.
6. Process Improvement: Collaborate with teams to identify and implement process improvements for clinical quality systems.
7. Regulatory Compliance: Stay updated on regulations and industry trends, interpreting and communicating requirements.
8. Risk Assessment: Conduct risk assessments, develop mitigation strategies, and ensure controls are in place.
9. Collaboration and Communication: Build relationships with internal and external stakeholders to facilitate audits, inspections, and submissions.

Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, or related field; higher degrees are a plus.
• 5+ years of clinical quality assurance experience, including audits and inspections.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.
• Understanding of clinical trial processes.
• Strong analytical, problem-solving, and leadership skills.
• Excellent communication skills.
• Attention to detail and accuracy.
• Relevant certifications (e.g., CQA, CCRP) are desirable.
• Knowledge of risk-based quality management is a plus.
• Fluent in English; proficiency in Word, Excel, PowerPoint.
• Willingness to travel internationally as needed.

What TRIO Can Offer You:

• Competitive compensation with annual reviews.
• Vacation, paid holidays, personal/sick days, volunteer days.
• Comprehensive health/medical plans.
• Retirement plan with up to 5% match.
• Flexible hours and remote work options.
• Home office stipend and internet allowance.
• International work opportunities.
• Employee assistance and recognition programs.

Pay Range: $80,000.00 to $110,000.00

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Research Services