[Hiring] Research Quality Manager @Sarah Cannon Research Institute

Role Description

The 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. This is a remote position in the US; relocation assistance and visa sponsorship are not available.

• 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

• 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 to support physical, mental, and financial well-being
• Competitive compensation package determined by performance, experience, skills, equity, job market evaluations, and geographical markets
• Other compensation, such as an annual bonus or long-term incentive opportunities may be offered

Company Description

Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.