Indiana Hemophilia & Thrombosis Center, Inc.

QA Engineer

• Oversee and continuously improve the clinical research quality management system in conjunction with IHI leadership
• Evaluate existing studies through auditing
• Develop training programs for new and existing research staff
• Maintain and develop QA Standard Operating Procedures and Work Instructions
• Review functional area SOPs relating to clinical research activities
• Oversee internal investigations and the CAPA program
• Conduct internal audits for compliance with sponsor protocols, GCPs, SOPs, and applicable regulations
• Document and report audits and produce audit certificates
• Create, update, and maintain the annual audit schedule
• Develop and review standardized procedures and workflows for research topics
• Develop CAPA plans and review CAPA trends quarterly
• Prepare and assist with FDA Inspections and host inspections when requested
• Conduct advanced research training for physicians and APPs
• Mentor and advise research staff and review study documents, including IIS protocols
• Conduct monthly QA presentations for research staff
• Update research staff on regulatory changes and guidance documents
• Train external, non-IHI personnel
• Participate in the Research Leadership Team and new study selection process
• Interview and hire new staff and resolve research-related issues
• Serve as a research regulatory advisor
• Supervise a small independent team of Research staff
• Perform other related duties as assigned

Director of Quality Assurance – Clinical Research