Clinical Operations

• Responsible for implementing the quality assurance program
• Managing and performing consult/support visits at investigative sites
• Assisting with onsite external audits and inspections
• Providing routine quality support for assigned investigative sites
• 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

Research Clinical Quality Manager

• Serve as a key resource for practice integration activities, clinical policy development, staff training, and value-based care initiatives.
• Develop, implement, and monitor standardized clinical workflows and best practices across physician practices.
• Assess clinical operations and identify opportunities to improve staff productivity, patient flow, care coordination, and operational performance.
• Support implementation of enterprise-wide clinical initiatives and operational improvement programs.
• Participate in clinical due diligence activities for practice acquisitions, affiliations, and de novo developments.
• Conduct periodic audits and assessments to evaluate compliance with organizational policies, accreditation standards, and regulatory requirements.
• Design, implement, and maintain onboarding programs for clinical staff across the physician practice portfolio.

Clinical Operations Manager – Practice Operations

• Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
• Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
• Providing strategic input into study feasibility, start-up planning, and early budget development
• Ensuring contracts and budgets comply with company policies, regulatory standards, and regional requirements
• Collaborating closely with Clinical Operations, Finance, Legal, and study teams to drive timely execution and approvals
• Identifying financial, operational and regional risks and proactively proposing mitigation strategies
• Tracking contract and budget performance, reporting trends and key metrics
• Driving continuous improvement initiatives to enhance efficiency, consistency, and best practices
• Acting as a subject matter expert on contract templates, budget models, and industry standards

Clinical Operations jobs in Tennessee

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Research Clinical Quality Manager

Clinical Operations Manager – Practice Operations

Senior Specialist, Clinical Operations – Contracting & Budgeting