Senior Quality Review Specialist, RN, Stem Cell, Oncology

About City of Hope,
City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas.

The successful candidate:

The FACT RN Quality Review Specialist develops, maintains and oversees the City of Hope-Atlanta (COH-ATL) Quality Management Plan, along with the development and review of processes and policies in collaboration with the COH-ATL Cellular Therapies Medical Director and Operations leadership. The Quality Coordinator coordinates continuous process improvement activities including audits of critical processes to ensure compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards.

This position will report to the Director of Quality, Regulatory, and Compliance

• Area of Focus: Heme/Stem Cell Oncology Program

• Maintains and oversees the quality management system plan, data and information management processes, procedures, and associated documents, and records required for compliance with Food and Drug Administration (FDA) regulations, Foundation for the Accreditation of Cellular Therapy (FACT) standards, The Joint Commission and other applicable agencies.

• Performs audits and analysis to evaluate the effectiveness of quality management plan, compliance processes, and controls.

• Host and lead federal, state and other accrediting bodies in regulatory audits and inspections

• Maintains establishment and product licenses/accreditation and regulatory files.

• Provides quality, data management, and regulatory compliance expertise, advice, and/or assistance across organizational lines

• Collaborates with the quality and data management personnel of critical third-party service providers (i.e., Collection, Cell Processing, IEC Manufacturers); collate data/information from critical third-party service providers for outcome analysis

• Perform audits of the accuracy of clinical data, accuracy of the data contained in the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Med-A Forms of the EBMT. Audit of safety endpoints and immune effector cellular therapy toxicity, and audits of external facilities performing critical and contracted services to ensure conformance with agreements.

• Coordinates and manages audits/inspection process. Ensures compliance with regulatory requirements and accreditation standards to include but not limited to FDA, FACT, CAP, TJC, CMS, and OSHA. Advises management staff on the status of compliance with current regulations, directives, and inspection findings.

• Coordinates and maintains Accreditation Standards: annual survey and renewal, survey distribution, deficiency response follow-up, the routing, documented review and retrieval of survey documents, and survey archiving.

• Maintains applicable establishment accreditation, product licenses and regulatory files.

• Performs analysis and makes recommendation/changes to achieve program strategic goals. Work includes developing and implementing performance measures/quality indicators, data collection and statistical analysis for continuous improvement.

• Monitors, reviews department processes; recommends and assists with facilitating quality improvement efforts, as needed; reviews final data reports, maintains documentation and follow-up to system deficiencies.

• Coordinates and directs variance reporting activities to include: the distribution and retrieval of incoming and outgoing variance report documents, applicable department investigation, review and follow-up, on-line documentation of variances into the hospital Quality System database and where applicable event/deviation/adverse reaction reporting with external agencies including but not limited to CAR-T Manufacturers, regulatory, and accrediting agencies.

• Collaborates in decision making and assisting with the establishment of policies and protocols.

• Maintains proficiency and knowledge regarding ongoing changes, regulatory requirements, accreditation standards, and industry practices.

• Compiles cellular therapy Specialty Quality Data reports and presents reports as requested. Responsible for preparation and timely submission of quality management reports to internal stakeholders as requested and external stakeholders as required.

• Maintains position related competencies and requirements.

• Responsible for the development of Standard Operational Procedures (SOP) and oversight of staff training on SOP’s.

Minimum Education:

• Bachelor’s Degree required, Master's degree preferred

• Active RN licensure in good standing in the state of employment

• OCN, BMTCN

• Statistical analysis experience preferred

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Minimum Experience:

• Minimum 5-years HSCT-CT Experience

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our comprehensive benefits, click here:Benefits Information

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.