Senior Clinical Quality Assurance Auditor

Translational Research in Oncology; Toronto; Remote; CAD 80,000 - 110,000; Full time

Job summary

A global academic clinical research organization is seeking a Senior Clinical Quality Assurance Auditor. This remote role involves conducting audits, ensuring compliance with regulations, and providing training on quality assurance practices. The ideal candidate will have extensive experience in clinical QA and a strong understanding of regulatory requirements. Join a passionate team committed to advancing oncology research with competitive salary and comprehensive benefits.

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Retirement Plans

Flexible Work Arrangements

Paid Time Off

Volunteer Days

Professional Growth Opportunities

Qualifications

• Minimum 5-8 years of experience in clinical QA.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.

Responsibilities

• Conduct comprehensive audits of clinical trials.
• Develop and maintain audit and inspection documentation.
• Provide training on QA practices and regulations.

Skills

Analytical

Leadership

Communication

Attention to Detail

Education

Bachelor's degree in life sciences

Higher degrees preferred

Tools

Word

Excel

PowerPoint

Job description

Job Title: Senior Clinical Quality Assurance Auditor

TRIO, a global academic clinical research organization dedicated to advancing translational cancer research, is seeking an experienced Senior Clinical Quality Assurance Auditor. This role is internally referred to as Senior Clinical Quality Assurance Manager and is a remote-based position in Canada.

Responsibilities:

1. Conduct Audits: Plan and execute comprehensive audits of clinical trials, including trial master files, internal processes, investigator sites, CROs, and other entities to ensure compliance with regulations, guidelines, and SOPs.
2. Host Audits/Inspections: Support sponsor audits and regulatory inspections, including preparation, conduct, and developing CAPA responses.
3. Quality Assurance Documentation: Develop and maintain audit and inspection documentation, ensuring accuracy and timeliness.
4. Training and Education: Provide training on QA practices, regulations, and industry standards to staff and stakeholders.
5. Quality Management System: Support the development and maintenance of the organization's QMS, including procedures and metrics analysis.
6. Process Improvement: Collaborate on process improvements and implement best practices for clinical quality systems.
7. Regulatory Compliance: Stay updated on regulations and communicate requirements to ensure compliance.
8. Risk Assessment: Conduct risk assessments and develop mitigation strategies.
9. Collaboration and Communication: Maintain effective relationships with internal teams and external partners, including auditors and regulators.

Requirements:

• Bachelor's degree in life sciences, pharmacy, nursing, or related field; higher degrees preferred.
• Minimum 5-8 years of experience in clinical QA, including audits and inspections.
• Deep knowledge of GCP, ICH, FDA, EMA, and regional regulations.
• Understanding of clinical trial processes.
• Strong analytical, leadership, communication, and attention to detail skills.
• Relevant certifications (e.g., CQA, CCRP) are highly desirable.
• Fluent in English, with proficiency in Word, Excel, PowerPoint.
• Willingness to travel internationally as needed.

What TRIO Offers:

• Competitive salary ($80,000 - $110,000) influenced by experience and qualifications.
• Comprehensive benefits including health, dental, vision, life insurance, and retirement plans.
• Flexible work arrangements, paid time off, volunteer days, and other employee benefits.
• Opportunities for professional growth and development.

Join TRIO and be part of a passionate team committed to making a difference in oncology research!