Sarah Cannon Research Institute · 11 hours ago
Sr Clinical Quality Assurance Analyst - Remote US
United States
Full-time
Remote
Senior Level
7+ years expSarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing therapies for cancer patients. The Sr Clinical Quality Assurance Analyst is responsible for ensuring compliance with SOPs, FDA guidelines, and ICH-GCP standards while supporting the Quality Management System and quality initiatives.
Responsibilities
Lead and support Research Quality activities to ensure adherence to policies and procedures, ICH-GCP, FDA guidelines, and applicable local/federal regulations
Contribute to the development and maintenance of policies, procedures, and controlled documents for Research Quality and supporting business units
Assist in implementing risk-based quality support structures and tools to monitor compliance and performance
Deliver training on quality assurance initiatives, regulatory compliance, and industry best practices
Foster a culture of continuous improvement, patient safety, and data integrity
Provide leadership in managing and sustaining robust document and change control programs
Lead research quality processes to ensure compliance with SOPs, ICH-GCP, and local/federal regulations
Serve as key subject matter expert and point of escalation with internal and external customers on all investigations and quality related issues
Assist with preparation for external audits, inspections, and quality oversight activities
Support communication with sponsors and regulatory agencies as directed
Contribute to inspection readiness activities and maintain compliance documentation
Other duties as assigned
Qualification
Required
Bachelor's degree in Science, Engineering, Life Sciences, Clinical Research, Quality Assurance or related field required
7+ years of progressive experience in clinical research quality assurance or regulatory monitoring with demonstrated expertise in leading complex quality initiatives
5+ years of quality assurance and oversite of clinical software
Proficient in applying risk-based approaches to software validation, ensuring compliance with regulatory requirements and industry expectations
Recognized expertise in FDA guidelines, ICH-GCP principles, and applicable regulatory requirements
Proven ability to influence and achieve results through collaboration in a matrixed environment
Strong understanding of compliance frameworks and risk-based quality management
Preferred
advanced degree preferred
Benefits
Comprehensive benefits to support physical, mental, and financial well-being
Competitive compensation package
Annual bonus or long-term incentive opportunities
Company
Sarah Cannon Research Institute
Sarah Cannon Research Institute is one of the world’s leading oncology research organizations conducting community-based clinical trials.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Deepak Bhamidipati
Assistant Director of Drug Development
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