This position provides program management for the Cellular Therapy Program. The program includes adult and pediatric clinical programs providing cellular therapy products to eligible patients. Responsibilities include program development, coordination, and advocacy; program operations; patient enrollment; tracking of operational and financial data; management of regulatory requirements and compliance; quality management; and maintenance of program data.
As a part of accomplishing program goals, this position will interface with nurse managers on 14K, DCH 10S and outpatient infusion, adult and pediatric nurse coordinators, Cellular Therapy Lab (CTL) manager and technicians, and Apheresis Unit manager and nurses. This position will be the content expert for and interface with Patient Billing Services (PBS), Hospital Financial Services (HFS), coding personnel, and Managed Care Contracting.
The incumbent must be self-directed while working both independently and in collaboration with the Cellular Therapy Program Medical Directors and the Cellular Therapy Program Director.
Function/Duties of PositionProgram Development and Management:
Development of the program’s infrastructure to include work processes withnurse coordinators, Apheresis Unit, CTL, Pharmacy Supply Chain and Logistics,
and Patient Business Services.Contact person identified on the OHSU web site for program inquiries.Develops standard work process breakdown documents for all aspects of the
program – patient enrollment, patient scheduling, product PO requests and
monitoring, assists nurse coordinators in development of patient education
documents.Co-facilitates development of new business as additional cellular therapy
products become FDA approved alongside the Cellular Therapy Program
Director. Ensures the certification audit process results in approval; submits
required adult and pediatric program information; sets-up initial training of
physicians, APPs, nurse coordinators, and nursing staff with the managers of
each department (IP Units, OP).Works collaboratively alongside the Cellular Therapy Program Director with the
adult and pediatric Cellular Therapy Program Medical Directors to achieve
program objectives.Monitors and reports on program performance.
Operations:
Coordinates and manages the day-to-day operations of the Cellular TherapyProgram:Enrolls patients on pharmaceutical companies’ electronic applications
(e.g., Cell Chain, Kite Konnect).Requests PO numbers from Pharmacy at time of patient enrollment.Tracks all patients and key information (product PO#, collection date,
preparation dates, infusion dates, manufacturing patient identifier).Tracking of Pediatric patient remission status and submission of
appropriate form to Novartis in the case of non-remission per
outcomes based agreementParticipates in the creation of Epic forms and smart phrases alongside
RNC’s needed for patient management; used by physicians, APPs,
nursing (e.g. CRS, neuro toxicity, neuro assessment documentation).
Finance:
Monitors financial reports for correct routing of revenue and expenseassociated with cellular therapy products.Ensures that required forms are submitted to pharmaceutical companies to
support contractual provisions for payment/non-payment.Establishes and maintains knowledge of commercial payer requirements
related to coding and billing. Subject matter expert with Patient Business Services, Hospital Financial
Services, coders and Oncology Financial Counselors.Establishes and maintains knowledge of Medicare rules and regulations, coding
and billing. Taps into resources available from the ASTCT and Product
Manufacturers.
Regulatory:
This position is the delegate or Second-Designee for the AuthorizedRepresentative who oversees the implementation and compliance with the
Risk Evaluation and Mitigation Strategy (REMS) Program for all pharmaceutical
companies with which OHSU is certified to dispense their cellular therapy
product. To that end, this position will work to:
Helps to maintain records of faculty and clinical staff training for
internal compliance.Ensures Pharmacy verification of Tocilizumab is on-site per REMS
requirement.Helps facilitate annual refresher training of faculty and staff.Be the point person for CAR-T related audits performed by
pharmaceutical companies per FDA requirementsReport adverse events related to CRS and neurological toxicities to the
pharmaceutical company and/or the FDA.
Quality Management:
Facilitates the CAR-T Patient Review and Program Development/Improvement& Research Updates meetings:Prepares agendas, participates in presenting cellular therapy program
quality and outcomes data, takes and distribute meeting minutes when
applicable, ensures follow-up items from meetings are completed.Coordinates with BMT program staff on ensuring compliance with FACT
standards for Immune Effector Cells.
Maintains competency and professional standard of practice through participation in continuing education and professional activities. Participates on a national level in organizations doing work in the area of cellular therapies (e.g., American Society of Transplantation and Cellular Therapy (ASTCT).
Required Qualifications BA or BS in health care administration, public health, public policy, business administration, or in a scientific field related to oncology.5 years of experience in a healthcare setting. Two of the required years must have included program development, and/or administration and oversight of an on-going project or program. Experience in oncology – program development and/or clinical trialsStrong organizational skills.Work process documentation experience.Ability to prioritize work.Self directed; work independently and collaboratively.Demonstrated judgement, tact, and ability to work with a variety of diverse customers – broad spectrum of departments, physicians (internal and referring), patients, and pharmeceutical firm representatives.Strong communication and leadership skills.Meeting facilitation skills.Competency in word processing, and EMR. Strong Excel skills.Compliance with Code of Conduct, Respect in the workplace and Applicable policies, procedures and agreements related to position, department or OHSU as a whole
Must be able to perform the essential functions of the position with or without accommodation
Preferred Qualifications Experience in/knowledge of or stem cell transplant.Regulatory program compliance.Oracle application experience Financial report analysisEpic Hospital billing (Resolute) All are welcome Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.