Senior Clinical Quality Assurance Auditor at Translational Research in Oncology Georgia

Translational Research in Oncology; Georgia; Remote; USD 70,000 - 90,000; Full time

Job summary

A clinical research organization is seeking a Senior Clinical Quality Assurance Auditor to conduct audits, ensure compliance, and maintain QA documentation. This remote position offers annual compensation of $70,000 to $90,000, with additional benefits including health insurance, flexible hours, and vacation days. The ideal candidate will have extensive experience in quality assurance within clinical trials and a strong understanding of regulatory requirements.

Benefits

Annual compensation review

3 weeks of vacation

Top-tier health/medical plan

401(k) matching program

Flexible working hours

Remote work arrangements

Qualifications

• 5+ years of experience in clinical quality assurance, preferably in pharmaceutical, biotech, or CRO.
• In-depth knowledge of GCP, ICH, and FDA/EMA regulations.
• Excellent written and verbal communication skills required.

Responsibilities

• Conduct comprehensive audits of clinical trials.
• Assist in hosting audits and inspections.
• Develop and maintain QA documentation.

Skills

Clinical quality assurance

Regulatory compliance

Analytical skills

Leadership

Communication

Attention to detail

Education

Bachelor's degree in a relevant scientific field

Master’s or PhD

Tools

Word

Excel

PowerPoint

Job description

Overview

Senior Clinical Quality Assurance Auditor at Translational Research in Oncology (TRIO), Georgia. Internal title: Senior Clinical Quality Assurance Manager. Remote-based in the United States. TRIO is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our team is committed to providing cancer treatments of the future to today’s world. TRIO is seeking a Senior Clinical Quality Assurance Auditor to join our Quality Assurance team. Reporting to the Senior Director of Quality Assurance.

Responsibilities

• Conduct Audits: Plan and execute comprehensive audits of clinical trials, including auditing clinical trial master files, internal processes, investigator sites, CROs, and other relevant entities to assess compliance with regulations, guidelines, and SOPs.
• Host Audits/Inspections: Assist in hosting Sponsor audits and Regulatory Authority inspections, coordinating preparation and conduct of the audit/inspection, and developing responses (CAPA) to findings.
• Quality Assurance Documentation: Develop and maintain QA documentation, including audit plans, audit reports, inspection readiness plans, and other relevant documents. Ensure accurate and timely documentation of audit findings, observations, and corrective actions taken.
• Training and Education: Provide training and guidance to internal staff and external stakeholders on QA practices, regulations, and industry standards related to clinical research. Foster a culture of quality and compliance through educational initiatives and ongoing support.
• Quality Management System: Provide support in developing and maintaining the Quality Management System of the organization, including creation and revision of written procedures, and conducting trending and metrics analysis for QA activities.
• Process Improvement: Collaborate with cross-functional teams to identify areas for process improvement and develop strategies to enhance the efficiency and effectiveness of clinical quality systems. Implement best practices and drive continuous improvement initiatives.
• Regulatory Compliance: Stay updated with current regulations, guidelines, and industry trends pertaining to QA. Interpret and communicate regulatory requirements to ensure compliance across clinical research activities.
• Risk Assessment: Conduct risk assessments to identify vulnerabilities and develop risk mitigation strategies with appropriate controls.
• Collaboration and Communication: Foster strong working relationships with internal stakeholders (clinical operations, regulatory affairs, data management, etc.) and external parties (auditors, regulatory authorities, vendors) to facilitate audits, inspections, and regulatory submissions.

Requirements

• Bachelor's degree in a relevant scientific field (life sciences, pharmacy, nursing). A Master’s or PhD is advantageous.
• Minimum 5 years of experience in clinical quality assurance (8+ preferred), including conducting audits and inspections in pharmaceutical, biotechnology, or CRO settings.
• In-depth knowledge of GCP, ICH, and regional requirements (e.g., FDA, EMA).
• Strong understanding of clinical trial processes, including study design, protocol development, data management, and adverse event reporting.
• Excellent analytical and problem-solving skills with the ability to evaluate data, identify trends, and propose solutions.
• Demonstrated leadership abilities, including mentoring junior team members and collaboration across cross-functional teams.
• Excellent written and verbal communication skills; ability to convey audit findings to various stakeholders.
• Attention to detail and commitment to accuracy and quality.
• Relevant certifications (e.g., CQA, CCRP) are highly desirable.
• Knowledge of risk-based quality management principles and risk assessment methodologies is a plus.
• Fluent English (oral and written) is required.
• Intermediate proficiency in Word, Excel, and PowerPoint.
• Ability to travel worldwide (Europe, North America, Asia, and occasionally other locations) as needed.

What TRIO Can Offer You

• Annual compensation review with opportunities for professional growth
• 3 weeks of vacation plus paid December Holiday Closure
• 10 days paid personal/sick time
• 1 paid volunteer day per year
• Top-tier health/medical plan for you and your family – monthly premiums paid by TRIO
• Up to 5% matching 401(k) program
• Flexible working hours to promote work-life balance
• Monthly internet allowance to support working from home
• Remote work arrangements anywhere across the USA with a one-time home office allowance
• Mobile phone stipend for qualifying positions
• Out-of-country work: ability to request international work for short periods
• Employee Family Assistance Program
• Employee Recognition Program
• Employee Referral Bonus Program

Pay Range: $70,000.00 to $90,000.00 – Salary to be influenced by education, experience, location, knowledge, skills, abilities, internal equity, and market data.

Teamwork · Passion · Integrity · Innovation