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Responsibilities
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 colleaguesMonitors and modifies policies and proceduresUtilizes quality tools that assess the quality indicators of study operationsMonitors quality indicators for all sites using Risk-Based approach and within framework of QBD – Quality by Design - and prioritizes quality indicators depending on severity/urgencyIdentifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleaguesAssists the business in development and modification of process documentsAssists with preparation and hosting of external auditsAssists research staff in maintaining regulatory compliancePerforms 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 trendsOther duties as assignedQualifications neededBachelor’s Degree required, Master’s Degree preferredMinimum 3 years’ work experience lity Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences fieldExpertise and other applicable regulations in a risk-based environmentAbout Sarah Cannon Research InstituteSarah 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. Please click here to learn more about our research offerings.We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. er compensation, such as an annual bonus or long-term incentive opportunities may be offered.
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