Description

About City of Hope

City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.

Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution.  AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.

A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California, Arizona, Illinois and Georgia. 

Job Description:

Cellular Therapy Quality, Regulatory, and Compliance

JOB SUMMARY

Reporting to the Director of Quality, Regulatory, and Compliance. The Data Management and Quality Compliance Coordinator is responsible for establishing the data management infrastructure, processes, procedures, guidelines, and performance measurement system that will be used to monitor and evaluate the overall performance and effectiveness of COH Atlanta Hematologic Malignancy and Cellular Therapy Institute (CAHCTI) in achieving goals for clinical and patient-centered excellence, quality, regulatory compliance, growth, financial health, and sustainability. The Data Management and Quality Compliance Coordinator will collect, monitor, and analyze critical data/information used to develop and submit timely reports required by accreditation and regulatory agencies, and registries such as the Center for International Blood and Marrow Transplant Registry (CIBMTR). Develop reports for quality committees and executive leadership reviews across organizational lines to inform decisions and shape the strategic direction of CAHCTI. Ensures compliance with all applicable requirements mandated by federal, state, and accreditation agencies. Performs internal audits of data accuracy and integrity as required by regulatory and accreditation agencies. Assists with the evaluation of effectiveness of the Quality Management System (QMS)-Performance Excellence Framework (PEF). Lead improvement initiatives, conducts training programs, direct internal and external audits, and other quality management functions. Supports industry best practices and corporate objectives.

JOB RESPONSIBLITIES

• Designs, develops, and maintains quality management system (QMS), 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, and other applicable agencies.

• Performs audits and analysis to evaluate the effectiveness of QMS, 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.

• Maintain complete and accurate data necessary to complete the Transplant Essential Data Forms of the CIBMTR or the Minimum Essential Data-A forms of the EBMT.

• 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, OSHA, and ISO. 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. Supports industry best practices, corporate objectives.

• 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.

• Actively involved 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.

• Performs improvement/research activities including abstract data analysis and writing.

• Maintains position related competencies and requirements. 
  
  

JOB QUALIFICATIONS

REQUIRED

• Experience-Minimum 2-years' experience in healthcare setting

• Education-bachelor’s degree

PREFERRED

• Certification-Six Sigma Black Belt, ISO 9001 Auditor Certification

• Special Skills- Statistical analysis experience preferred.
  
  

Pay Range

$64,411.78 - $106,120.56

Placement within the identified pay range is based on individual and market factors including, but not limited to, experience, education, credentials (including licenses and certifications), geographic location, market competition, skill set (including market availability of required skills), assigned/anticipated job tasks, and level of responsibility.  These factors are considered without regard to an individual’s status as a member of any protect group pursuant to federal, state, and/or local law.

City of Hope’s commitment to Diversity, Equity, and Inclusion

We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities.  Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds, and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding.  We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds, and perspectives; this is reflected in our work and represented in our people.

Visit:  Jobs.cancercenter.com to begin your journey.