Research Quality Manager

It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. 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.  This is a remote position in the US; relocation assistance and visa sponsorship are not available. 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…