Clinical Quality Analyst

Employment Duration: 6 months

Note: This position will be fully remote.

The Hematology, Blood and Marrow Transplant and Cellular Therapy (HBC) Quality Management Analyst plays a key role in developing, coordinating, managing, and executing quality activities under the direction of the Quality Nurse Manager, Director of Operations, and HBC Medical Director. The position works collaboratively with clinical and operational leaders across Infusion, Apheresis, inpatient and outpatient clinical units, and the Blood and Marrow Transplant Lab to support quality initiatives, data management, regulatory compliance, and operational efficiency.

This experienced quality professional independently manages, plans, and administers data and quality activities for the Adult HBC program. The role abstracts, trends, analyzes, and synthesizes clinical data and quality metrics; develops reports, audits, dashboards, and presentations; monitors quality benchmarks; supports regulatory and accreditation activities; and contributes to short- and long-term quality improvement strategies. 

The UCSF Helen Diller Family Comprehensive Cancer Center Adult Hematology, Blood and Marrow Transplant and Cellular Therapy Program provides patient-centered care for individuals with acute and chronic blood conditions and is a leader in blood and bone marrow transplantation and cellular therapies. The multidisciplinary team includes physicians, nurses, social workers, and other health professionals who support patients and families throughout the transplant and cellular therapy process.

Key Responsibilities

Quality Management and Program Operations

• Participate in strategic planning and align quality activities with program goals, including short- and long-term planning and regulatory compliance.
• Engage stakeholders to promote quality and safety, including regulatory preparedness and compliance activities related to document control, FACT, and REMS.
• Analyze quality initiatives and program functionality, quality, and efficiency using data and analytics.
• Analyze quality-related problems and issues and collaborate with the Quality Nurse Manager, Director of Operations, and Medical Director on solutions.
• Support implementation of regulatory standards, regulatory awareness, staff training, and preparation for external audits.
• Manage records and documentation required for FACT, NMDP, and other regulatory and trending needs.
• Coordinate Quality Management Committee, Consent Committee, CAR T working group, and FACT working group agendas and follow-up activities.
• Attend quality meetings, take minutes, track action items, and obtain needed information from stakeholders.
• Review and standardize reports for quality meetings, including incident reports, audit reports, dashboards, ICU admissions reports, and deviations.
• Pull and maintain ICU admissions and outpatient incident-report data, working with IT on APeX reporting as needed.
• Represent the quality department on the Consent Committee and participate in Triangle and CIBMTR working groups.
• Coordinate quality information and dashboard reporting with staff and departments.
• Coordinate with IT on Standard Operating Procedures downtime computers and maintain downtime binders across inpatient, clinic, and pharmacy areas. 

Compliance, Regulatory, Accreditation, and External Recognition

• Maintain awareness of statutory and regulatory requirements, including FACT, NMDP, CIBMTR, CMS, and FDA REMS.
• Coordinate and participate in survey and accreditation readiness activities.
• Gather, maintain, and organize documentation for site visits and inspections.
• Develop plans to address audit deficiencies and follow up with appropriate staff.
• Prepare and evaluate FACT submissions, including inspection submissions, requests for information, and annual reports.
• Evaluate compliance with internal and external documentation, outcomes, reportable-event, clinical-practice, service-quality, and outcome requirements.
• Develop and manage controlled quality documents and review, edit, format, and standardize document control content.
• Assist the Authorized Representative for standard-of-care CAR T-cell therapies.
• Serve as a point of contact with accrediting and regulatory bodies and as a primary quality contact for standard-of-care CAR T-cell therapies with pharmaceutical representatives, quality teams, and medical science liaisons.
• Prepare quality-related presentations for HBC team meetings.
• Maintain equipment and maintenance records and review quality agreements, MOUs, and other agreements as directed.

Data Management, Measurement, and Analytics

• Compare data sources to establish benchmarks and collect and validate quality data.
• Participate in identifying and selecting structure, process, and outcome measures.
• Support risk assessment reviews and complete or assist with risk assessment reports.
• Gather, analyze, and prepare audits of Standard Operating Procedure compliance and ensure quality activities meet deadlines.
• Track BMT/CAR T quality dashboard information and complete required quarterly and annual reporting.
• Review medical records, including clinical notes, laboratory results, diagnostic studies, and consent documentation, and abstract data for audits, case reviews, and validation.
• Review standard-of-care CAR T-cell patient records to trend clinically significant areas and ensure CIBMTR and FDA documentation requirements are met.
• Submit or delegate FDA adverse-event reports for standard-of-care CAR T-cell patients when required by manufacturer requirements.
• Review audit requirements and update benchmarks with the Quality Manager based on updated quality standards and data trends.
• Analyze and interpret complex data; summarize findings; and develop reports, dashboards, presentations, action plans, recommendations, and summaries.
• Support clinical quality areas with data-management activities and projects. 

Education, Training, and Communication

• Develop and maintain document control training materials and handouts.
• Develop and coordinate staff training plans for onboarding standard-of-care CAR T-cell therapies.
• Maintain staff training records for FDA-required REMS programs.
• Participate in REMS compliance activities with pharmaceutical companies.
• Coordinate additional staff-training opportunities related to standard-of-care CAR T-cell therapies.
• Disseminate performance, process, and quality-improvement information throughout the program.
• Serve as a resource to staff on document control.
• Manage document control user, platform, document-management, troubleshooting, and technology-ticket issues.
• Coordinate initial and ongoing document control training and ensure user tasks are completed and documented.
• Coordinate document control user-management activities and maintain current personnel information.
• Coordinate attendee lists and Box folders for relevant quality and program meetings. 
   

Performance and Process Improvement

• Participate in identifying needs for CAPAs/A3s and complete or assist with A3 reports.
• Trend planned and unplanned deviations annually and determine, with Quality Manager review, whether A3s are necessary.
• Participate with the Quality Nurse Manager and Medical Director in identifying quality-improvement opportunities and establishing priorities.
• Take an active role in implementing performance-improvement methods.
• Support the Department of Quality's annual CPIC reporting.
• Analyze document control workflows and processes and make changes as needed.
• Assist in developing policies and procedures that promote efficient workflows.
• Assist the Quality Nurse Manager with cost-effective and scalable process changes.

Implementation and Evaluation

• Manage project schedules, timelines, and action items related to implementation of standard-of-care CAR T-cell therapies.
• Review, plan, edit, and delegate updates to controlled CAR T-cell therapy documents as new therapies are approved.
• Collaborate with pharmaceutical representatives regarding changes in processes, workflows, and requirements.
• Participate in streamlining CAR T-cell therapy workflows as therapies and requirements change.
• Create and assist with development of controlled program documents.
• Support implementation and oversight of controlled documents in document control.
• Perform document control program validations during UCSF upgrades.
• Monitor project timelines and deliverables.
• Participate in safety and risk-management activities, including incident review, unexpected-event review, root cause analysis, and failure mode and effects analysis.
• Work with the document control Program Manager to evaluate and implement applicable new document control features. 

Budget and Finance

• Assist with annual requests for information from agencies and payors.
• Review, prepare, and submit financial ASBMT information requested by health insurance companies and managed care organizations.
• Analyze document control license data to determine whether licensing levels are appropriate for program needs.
• Assist with notification processes and maintain follow-up lists for standard-of-care CAR T-cell patients who did not infuse to support reimbursement activities.

N/A

Required Qualifications:

• Knowledge of medical terminology.
• Excellent written and verbal communication skills.
• Ability to interact effectively and professionally with oncology staff and physicians.
• Experience with document-control systems or document-control processes.
• Knowledge and experience using EPIC.
• Proficiency with commonly used word-processing and spreadsheet applications, including Microsoft Office.
• Thorough knowledge of quality-improvement standards, clinical chart review and abstraction, and regulatory requirements.
• Knowledge of quality-improvement models, tools, and techniques, including data collection, abstraction, validation, analysis, reporting, and use of performance and benchmark indicators.
• Knowledge of and adherence to HIPAA requirements.
• Skills in short-term planning, analysis, problem-solving, and customer service.
• Critical-thinking and problem-solving skills with the ability to manage complex information and responsibilities.
• Strong interpersonal skills and the ability to collaborate effectively with clinical and technical staff and representatives of external regulatory agencies.
• Ability to communicate technical and educational information effectively verbally and in writing and produce quality reports, documentation, and presentations.
• Ability to work collaboratively with multiple stakeholders at varying levels of an organization.
   

Preferred Qualifications:

• Bachelor's degree in a clinical science, biological science, healthcare, or related field.
• Three years of related quality experience or an equivalent combination of education, training, and experience.
• Organizational and project-management skills, including the ability to prioritize multiple responsibilities and see projects through completion.
• Thorough knowledge of regulatory rules, regulations, processes, protocols, and procedures related to healthcare quality management.
• Knowledge of healthcare quality operations, analytics, regulatory requirements, and guidelines.
• Experience supporting healthcare audits, accreditation, compliance, or regulatory-readiness activities.
• Experience with MasterControl or a comparable electronic document-control/quality-management system.
• Experience in oncology, hematology, blood and marrow transplant, cellular therapy, or another complex clinical environment.