Cell Therapy and Transplant Quality Improvement Coordinator@ PAH

Penn Medicine, University of Pennsylvania Health System; Philadelphia (Philadelphia County); On-site; USD 95,000 - 135,000; Full time

Job summary

Penn Medicine's Abramson Cancer Center at Pennsylvania Hospital seeks a Senior CTT Quality Improvement Coordinator nurse to lead quality initiatives for the Cell Therapy and Transplant program. The role emphasizes regulatory readiness, policy maintenance, and cross-department collaboration to advance patient care in cellular therapies.

The position includes leading accreditation activities, data capture for outcomes, and staff onboarding with a strong focus on continuous improvement and

Qualifications

• RN license in PA
• 5+ years quality improvement or FACT inspection experience
• Experience coordinating cross-department quality initiatives
• Experience with document control and policy management
• Experience preparing for regulatory inspections (FACT, JCAHO)
• Experience in training and competency programs

Responsibilities

• Lead quarterly CTT quality committee meetings and coordinate reports and minutes
• Maintain CTT policy manual, consent forms, and clinical documentation
• Coordinate accreditation surveys and readiness activities with FACT and JCAHO
• Capture and modernize outcome metrics; produce data for payors and stakeholders
• On-board new CTT staff and ensure training and competency records
• Collaborate with Transfusion Medicine, Nursing, Pharmacy and other departments to drive quality improvements

Skills

Quality improvement

FACT inspections

Lean/Six Sigma

Education

Bachelor’s degree (BA/BS)

Master’s degree (MA/MS)

Tools

SharePoint

Epic

REDCap

Job description

Description

Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.

Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?

Join Pennsylvania Hospital's nationally recognized Cancer Program as a dynamic leader who will shape the future of oncology services, drive innovative program development, and advance exceptional patient-centered cancer care across the continuum.

The Abramson Cancer Center @ Pennsylvania Hospital (PAH) is hiring for a Senior CTT Quality Improvement Coordinator nurse to join their team.

Summary

• The Senior Cell Therapy and Transplant (CTT) Quality Improvement Coordinator will act as a leader and programmatic reference point for quality improvement initiatives at PAH. This includes development, maintenance, and evaluation of system processes in support of the CTT program including quality report out calendars/schedules and electronic data systems.
• This role will also develop, maintain, and evaluate the CTT program at HUP's policies, procedures, forms, and worksheets through the maintenance and upkeep of the CTT policy manual and non-policy clinical documentation (clinical guidelines, consents, etc.).
• This role will also lead educational initiatives for the CTT program at PAH and help develop training and competency initiatives in partnership with multidisciplinary teams caring for CTT patients.
• This role will lead ongoing accreditation reviews and inspections from cell therapy regulatory bodies, such as FACT, JCAHO, etc. This role will lead CTT and other multidisciplinary stakeholders in preparation for and performance of surveys by FACT, JCAHO, and other accrediting bodies.
• The position will also oversee inspections from outside manufacturers, for new and current cellular therapies, to ensure compliance with label indications and appropriate clinical care.

Responsibilities

• Maintain CTT program compliance to current version of FACT standards and other regulatory bodies, for such things as event reporting, recipient and donor care, facility requirements, quality requirements, etc. This position will be the primary contact with FACT and other regulatory bodies. This role will take a leadership role in preparing the CTT program at PAH for the clinical and bone marrow collection inspection by FACT. This role will collaborate with transfusion medicine and other hospital services to ensure inspection readiness. This role will complete at least 10 continuing education hours annually related to heme malignancies, quality improvement or cellular therapy/transplant.
• Maintenance of CTT’s policy manual (on SharePoint and paper downtime binders) including consents, worksheets, and forms. This includes developing a sustainable multidisciplinary review process with key stakeholders across the hospital and revising documents based on feedback and research. This includes maintenance of non-policy clinical documentation such as clinical guidelines, consents, etc. This role will include development of new policies and forms as CTT on-boards new therapies. This role will partner with the CTT leadership to modernize the document control, review, and form/consent use process.
• Lead and organize the CTT quality committee quarterly meeting, in collaboration with CTT physician chair, including scheduling, report requests, slide preparation, and minutes. Management of HUP CTT quality committee calendar and all reports included (such as event reporting, adverse reaction reporting, outcome reporting, auditing, validations, morbidity/mortality metrics, annual report of quality program, etc.) to evaluate program compliance to internal SOPs, FACT standards, and other regulatory bodies.
• Work with clinical leadership and CTT operations team to capture new outcome metrics and modernize data collection and reporting. Compile quality and survival data as requested to complete information requests from external parties, such as payors. Partner with CTT clinical team and CTT operations team to lead quality improvement initiatives based on internal/external outcome reporting, mortality and morbidity case report outcomes, auditing/inspection follow-up and other reports as directed by CTT or hospital leadership. Manages CTT Morbidity and Mortality conferences.
• Collaborates with other departments (transfusion medicine, nursing, pharmacy, etc.) and at a system level to develop quality initiatives, outcome report outs, and corrective actions plans (as needed) to improve program performance.
• On-boarding new CTT staff and FACT designated critical clinical personnel by sending policies for review and compiling personnel training and competency records per regulatory requirements. This role will collaborate with multidisciplinary teams throughout the hospital to develop and maintain training and competencies, including video education series, for current cell therapies and as new cellular therapies are on-boarded so all cell therapy stakeholders have the training they need to safely deliver cell therapies. This role will be an educational reference point for cellular therapies.
• This role will serve as the authorized representative for cellular therapy products with a Risk Evaluation Mitigation Strategies (REMS) program. This role will comply with REMS audits for PAH maintain documentation required for the FDA required program and adjust policies and procedures as appropriate for REMS requirements for HUP.

Credentials

• Registered Nurse - PA
• SSGB or LEAN or PM or PIC
• Six Sigma Green Belt or above or Lean Certification or Project Management or Process Improvement Certification

Education or Equivalent Experience

• Bachelor of Arts or Science (Required)
• Education Specialization: Nursing Equivalent Experience:
• Master of Arts or Science (Required)
• Education Specialization: Healthcare (Quality, Administration), Science, Business, or related field Equivalent Experience:
• And 5+ years Quality improvement or successful FACT inspection experience
• 0-1 years Quality improvement or successful FACT inspection experience
• 1+ years Previous experience with quality reporting in cell/gene therapy preferred
• 1+ years Policy or technical writing experience preferred
• 1+ years Experience with SharePoint, Epic and REDCap preferred

We believe that the best care for our patients starts with the best care for our employees. Our employee benefits programs help our employees get healthy and stay healthy. We offer a comprehensive compensation and benefits program that includes one of the finest prepaid tuition assistance programs in the region. Penn Medicine employees are actively engaged and committed to our mission. Together we will continue to make medical advances that help people live longer, healthier lives.

Live Your Life's Work

We are an Equal Opportunity employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.