Note: The job is a remote job and is open to candidates in USA. Sarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing cancer treatments. The Research Clinical Quality Manager is responsible for implementing quality assurance programs and supporting investigative sites to ensure compliance and quality in clinical research operations.
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
Skills
- Bachelor's Degree required
- 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
- Master's Degree preferred
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
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