Stem Cell Transplantation Quality & Safety Coordin
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Chicago, IL 60611
Stem Cell Transplantation Quality & Safety Coordinator
Requisition ID 2021-15442
Position Type Regular Full-Time
This position assumes accountability for ensuring ongoing assessment of the stability, reproducibility, and effectiveness of critical processes required for the Stem Cell Transplantation Program (SCTP) efficiency, safety, and achievement of desired patient care outcomes; and maintaining compliance with standards imposed by any regulatory agency related to the Stem Cell Transplantation Program.Responsibilities
1. Provides administrative oversight for all aspects of the Quality and Safety Plan for the Clinical, Bone Marrow and Therapeutic Apheresis arms of the Stem Cell Transplantation Program (SCTP); with accountability for ensuring effective implementation of said plans; serving as the primary quality communication across all arms of the SCTP to assure consistency between quality and safety policies and activities.
2. Acts as a primary resource for integrating SCTP regulatory requirements into Lurie Children’s Hospital policies, procedures and protocols interfacing as required with Lurie Children’s Hospital committees and councils to promote continuity and continuous progress to achieve and maintain compliance.
3. Collaborates with the Medical Director of the Stem Cell Transplant and Cellular Therapy Program, Collection Program Director, Apheresis Program Director and Director of Processing Facility to ensure the utmost quality of clinical care and cell product.
4. Responsible for abstracting necessary clinical data for SCT patients to fulfill reporting requirements to regulatory and accrediting agencies and research sponsors, as needed, and to track patients internally. Processes all charges/invoices related to search, procurement and lab processing for stem cell transplant patients.
5. Provides leadership for quality monitoring, process, data collection, analysis, and reporting for assessment, recommendations for improvements, and approval of corrective action plans: interfaces with Lurie Children’s Hospital councils/committees for quality compliance as warranted.
6. Performs data collection for all arms of the SCT Program: validation studies; qualification studies; quality control; inventory control and tracking; clinical outcomes measure; record review process; Service Excellence and family satisfaction data; Lurie Children’s Hospital best practices.
7. Oversees and participates in efforts to obtain and maintain the process of readiness for regulatory audits from the Food and Drug Administration (FDA) or other regulatory bodies including the Foundation for the Accreditation of Cellular Therapy (FACT).
8. Assures integration of SCTP form’s development in collaboration with Health Systems Management to assure compliance with applicable Lurie Children’s Hospital policies, protocols and procedures and accreditation requirements.
9. Collaborates with Nursing Clinical Governance Structure to ensure that STCP policies and procedures align with Lurie Children’s Pediatric Based competencies, policies, procedures, protocols and plans of care and collaborates with Clinical Education and SCTP Leadership to coordinate education and training.
10. Acts primary link for changes in standards and requirements by all regulatory agencies.
11. Other job functions as assigned.
1. Bachelor’s Degree in nursing or higher required.
2. Current licensure as a registered nurse in the State of Illinois.
3. 3-5 years of experience in a healthcare environment.
4. Experience in Oncology or Stem Cell Transplant preferred.
5. Familiarity and experience using the Microsoft Office Suite, Word, PowerPoint, Excel, etc.
6. Knowledge of and experience with QI principles and tools.
7. Knowledge of and experience with the development of policies, procedures and protocols.
8. Excellent oral and written communication skills.
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