OneOncology · 1 day ago
Manager, Research Quality
Nashville, TN
Full-time
Onsite
Mid, Senior Level
4+ years expOneOncology is positioning community oncologists to drive the future of cancer care through a patient-centric, physician-driven, and technology-powered model. The Manager, Research Quality will develop and lead a quality assurance program to support clinical research at the site level, ensuring compliance with regulatory requirements and fostering a culture of quality and continuous improvement.
Health CareOncology
Responsibilities
Develop and implement a site-level quality assurance program
Conduct a comprehensive gap analysis of existing processes, SOPs, and operational workflows against GCP guidelines and regulatory requirements. Based on gap analysis findings, develop a robust, fit-for-purpose quality program
Lead the development of all site-level SOPs, work instructions, and procedural documents to ensure they are standardized, compliant, and reflective of best practices
Assess training needs and collaborate with site leadership to develop curricula tailored to different roles; deliver training
Develop risk mitigation strategies and process improvement plans to address identified risks in systems and processes and enhance the overall quality and compliance of clinical research operations
As part of the OneR Quality team, collaborate closely with OneR Quality Control Specialists and Research Quality Auditors in facilitating QC and audit activities and addressing findings
With OneR Quality team support, participate in continuous inspection readiness activities
Collaborate with the OneR Regulatory team regarding promptly reportable events to the IRB
Collaborate with the practice’s compliance department as needed to ensure consistency between practice-level and research-specific policies
Lead CAPA development
Serve as day-to-day subject matter expert and resource for site personnel regarding quality-related questions and best practices
Other duties as assigned to help drive our mission of improving the lives of everyone living with cancer
Qualification
Required
4-8+ years of experience in clinical research quality assurance
Bachelor's degree required
Proficiency in Microsoft Office applicable and familiarity with quality management systems, electronic data capture (EDC) systems, electronic regulatory binders, and clinical trial management systems (CTMS), and other clinical research technologies
Must be based in the greater Nashville, TN area with the ability to travel regularly between Nashville area facilities; must also have the ability to travel to the site's Chattanooga area facilities
Preferred
Quality assurance experience on the sponsor/CRO side highly preferred
Experience supporting FDA inspections highly preferred
Clinical research and/or quality assurance certification highly preferred
Company
OneOncology
OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.
1001-5000 employees
H1B Sponsorship
OneOncology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Cencora
2025-12-12Acquired
2023-04-20Secondary Market
Leadership Team
Davey Daniel
Chief Medical Officer
Recent News
2026-01-05
2025-12-18
Company data provided by crunchbase