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Director of Quality Assurance – Clinical Research
Indiana Hemophilia & Thrombosis Center, Inc.. Oversee and continuously improve the clinical research quality management system in conjunction with IHI leadership .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical research quality assurance, including oversight of quality management systems, internal audits, and compliance with GCPs and regulatory standards. Capable of developing training programs and mentoring research staff while managing CAPA processes and preparing for FDA inspections.
Highest-signal resume keywords
Clinical Research Quality ManagementGCP Quality Assurance LeadershipInternal Audits and ComplianceCAPA Program ManagementTraining and Mentoring Research Staff
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Research ExperienceQuality Assurance ProceduresAudit DocumentationSOP DevelopmentRegulatory ComplianceFDA Inspection PreparationCAPA Plan DevelopmentResearch Protocol ReviewTraining Program DevelopmentData Analysis
Soft Skills
LeadershipMentoringCommunicationProblem-SolvingTeam Supervision
Industry Keywords
GCPClinical ResearchQuality Management SystemAudit ScheduleResearch Leadership TeamRegulatory ChangesResearch Staff TrainingInvestigational StudiesStandard Operating ProceduresCAPA Trends
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Minimum Bachelor’s degree in related field
- Preferred MS degree or higher
- Minimum 12 years of clinical research experience with at least 5 years in GCP quality assurance leadership position
- Valid driver’s license and insured automobile required
- Ability to travel to applicable conferences or meetings as required
- Ability to make quarterly visits to IHI or visit as otherwise needed for on-site training or Center-specific or Research-specific needs
Benefits
Comp & perks- Competitive salary and benefit package
- Opportunity to work for a not-for-profit program
- Participation in national and international clinical research
- Access to new therapies and opportunity to improve care
- Equal Opportunity Employer