Clinical Quality Analyst

UCSF Health is hiring a Clinical Quality Analyst to manage quality activities and data for its Adult Hematology, Blood and Marrow Transplant and Cellular Therapy program. The role supports clinical quality improvement, regulatory compliance and accreditation, analytics, document control, staff training, and implementation of standard-of-care CAR T-cell therapies.

Responsibilities

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 agreements as directed

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

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

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

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

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

Preferred

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

Three years of related quality experience or an equivalent combination of education, training, and experience.

Healthcare Quality Management

Healthcare Quality Operations

Healthcare Quality Analytics

Healthcare Quality Guidelines

Healthcare Quality Experience

Audit Support

Accreditation Support

Compliance Support

Regulatory Readiness

MasterControl

Electronic Document Control

Quality Management Systems

Oncology

Hematology

Blood

Marrow Transplant

Cellular Therapy

Complex Clinical Environments

Organizational Skills

Project Management

Prioritization

Project Completion

Benefits

This position will be fully remote.

Company

Integrated hospital and health care network

San Francisco, California, USA

https://www.ucsfhealth.org/

Founded in 1990

5001-10000 employees

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

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

Required skills

Medical Terminology, Document Control, EPIC, Microsoft Office, Clinical Chart Review and Abstraction, Healthcare Quality Improvement, Quality Data Collection and Analysis, HIPAA Compliance, Healthcare Regulatory Compliance, Healthcare Audits and Accreditation, MasterControl, Oncology and Hematology, Blood and Marrow Transplant, Cellular Therapy

Preferred skills

Written and Verbal Communication, Project Management

Experience

3+ years