Research Quality Manager

About the role

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.

Responsibilities

• 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

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

About Sarah Cannon Research Institute

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.

Benefits

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. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.