Research Quality Manager
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Job Description
Research Quality Manager overseeing quality assurance, audits, and regulatory compliance for Sarah Cannon Research Institute’s oncology clinical trials. Fully remote within the United States.
Responsibilities:
- Implement the quality assurance program
- Manage and perform consult/support visits at investigative sites
- Assist with onsite external audits and inspections
- Provide routine quality support for assigned investigative sites
- Develop and maintain relationships with investigative sites and SCRI departments and colleagues
- Monitor and modify policies and procedures
- Utilize quality tools to assess study-operation quality indicators
- Monitor and prioritize quality indicators for all sites using a risk-based approach and Quality by Design framework
- Identify and report quality deficiencies to directors and appropriate colleagues
- Assist in developing and modifying process documents
- Assist with preparing and hosting external audits
- Assist research staff in maintaining regulatory compliance
- Perform process/focused audits of research sites and report findings to leadership
- Ensure timely and appropriate follow-up on deficiencies
- Communicate observations and deficiencies to Site Directors/Managers and study PIs
- Assist sites with root-cause analysis and responses to external audits and CAPAs
- Maintain audit records and reports
- Communicate with clinical-trial monitors and auditors as needed
- Educate staff on quality-improvement methods and industry trends
- Perform other duties as assigned
Requirements:
- 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 supporting physical, mental, and financial well-being
- Annual bonus or long-term incentive opportunities may be offered
- Relocation assistance is not available
- Visa sponsorship is not available
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