Clinical Quality Auditor Jobs

The Clinical Quality Auditor (CQA) conducts audits and performs compliance-related services based on experience and a comprehensive understanding of regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP). As a Quality Assurance (QA) team leader, the CQA supports project teams as needed and assists with internal initiatives to ensure GCP-compliant clinical trial management services are in alignment with the MedTrials Quality Management System (QMS) requirements.

Responsibilities:

• Provide quality management system consulting services.
• Assist with Quality Management Plan development, review, and compliance oversight.
• Host client audits or other operational assessments and support regulatory inspections as assigned.
• Compliance-related documents.
• Provide project-specific compliance support as assigned (e.g., GCP/compliance
• Assist with risk management plan development, review, and compliance oversight
• Assist with the development, delivery, and documentation of training.
• Provide inspection readiness and/or compliance consulting and training (to include
• Assist with the development and oversight of project-specific plans.
• Mock inspections).
• Conduct contractor qualification assessments.
• Audit/inspection support).
• Support gap analyses.
• Maintain electronic files that can be accessed by appropriate personnel.
• Communications:
• (including Risk Assessment Worksheet completion).
• Conduct a regulatory review of training curricula as assigned.
• Conduct supplier qualification assessments.
• Develop, edit, review, and/or critique quality control documents (QCDs) or other
• Conduct quality audits (e.g., project, process, system, and supplier).
• Represent QA on project teams and other internal forums as assigned.
• Assist with the quality incident and complaint handling.
• Communicate effectively and objectively; give constructive comments and feedback.
• Assist with process improvement initiatives.
• Participate in the development, implementation, and evaluation of corrective and
• Improvement.
• Assist with staff onboarding.
• Questions, essential document development/review, CAPA plans, site activation,
• Preventive action (CAPA) plans to address deficiencies and promote process
• Conduct competency assessments as assigned.
• Agendas, and meeting minutes. Timely completion of assigned reports according to Quality System and project requirements.
• Write documents including but not limited to audit documents, QCDs, contact reports,

Qualifications:

• A combination of education, training, and experience may be considered in lieu of
• Minimum of 8 years of GCP-related experience.
• A Bachelor’s degree, preferably in science or a health-related field.
• Experience as QA Associate/Clinical Quality Auditor or in compliance/utilization review
• Able to travel a minimum of 20%, at times on short notice (less than 7 days).
• Education or experience requirements.
• Strong working knowledge of FDA-regulated research, ICH Guidelines, and GCP.
• Preferred.
• Current certification in clinical research or regulatory affairs is preferred.
• Must live within 50 miles of a regional or international airport.
• Proficient in Microsoft Office programs such as MS Word, Excel, PowerPoint, SharePoint,
• And Teams.