Research Quality Manager
Sarah Cannon Research Institute
Summary
Our Research Quality Manager is responsible for implementing the quality assurance program, managing and performing consult/support visits at investigative sites, assisting with onsite external audits and inspections, and providing routine quality support for assigned investigative sites.
Job description
Duties include but are not limited to:
- Develops and maintains effective relationships with investigative sites and other SCRI departments and colleagues
- Monitors and modifies policies and procedures
- Utilizes quality tools that assess the quality indicators of study operations
- Monitors quality indicators for all sites using Risk-Based approach and within framework of QBD – Quality by Design - and prioritizes quality indicators depending on severity/urgency
- Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues
- Assists the business in development and modification of process documents
- Assists with preparation and hosting of external audits
- Assists research staff in maintaining regulatory compliance
- Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.
- Ensures timely and appropriate follow-up in areas of deficiency.
- Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate.
- Assists sites with Root Cause analysis and responses to external audits and CAPAs.
- Maintains records of audits and reports.
- Communicates with monitors and auditors of clinical trials, as needed.
- Educates staff in quality improvement methods and industry trends
- Other duties as assigned
Qualifications needed
- Bachelor’s Degree required, Master’s Degree preferred
- Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field
- Expertise in GCP, FDA and other applicable regulations in a risk-based environment
Requirements
- Bachelor’s Degree required, Master’s Degree preferred
- Minimum 3 years’ work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field
- Expertise in GCP, FDA and other applicable regulations in a risk-based environment
Benefits
- Comprehensive benefits
- Physical well-being support
- Mental well-being support
- Financial well-being support
- Competitive compensation package
- Annual bonus
- Long-term incentive opportunities
Company overview
Sarah Cannon Research Institute (SCRI) is a premier oncology research organization and global leader in community-based clinical trials. Founded in 2004 through a joint venture between Tennessee Oncology and Hospital Corporation of America, SCRI has established itself as one of the world's leading cancer research institutions. With headquarters in Nashville, Tennessee, the institute operates across more than 200 locations in over 20 U.S. states and the United Kingdom, bringing together more than 1,300 research physicians. SCRI specializes in conducting first-in-human clinical trials, having completed over 850 such studies since its inception, and has contributed significantly to the development of approximately 10 FDA-approved cancer therapies since 1999. The organization focuses primarily on oncology research while also expanding into cardiology, gastroenterology, and other therapeutic areas. SCRI's unique community-based model enables patients to access cutting-edge clinical trials close to home, bridging the gap between academic research centers and local healthcare providers. The institute employs 501-1,000 professionals and maintains strategic partnerships with pharmaceutical and biotechnology companies to advance cancer treatment innovations.