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.

• 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.

• 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…