Transplant and Cellular Therapy Data Management Associateno

Department: 37339 Advocate Lutheran General Hospital - Administration:
Bone Marrow Transplantation (BMT)

Status: Part time

Benefits Eligible: Yes

Hours Per Week: 20

Schedule Details/Additional Information: 0.5 FTE, 3 eight‑hour shifts one week/2 eight‑hour shifts one week for a total of 40 hours every two weeks. No holidays, no weekends.

Pay Range: $26.55 - $39.85

• Use multiple complex databases and Web‑based systems, including the electronic medical record (EMR) and electronic data capture systems. Extract, analyze and enter the relevant data in a timely and accurate manner into the CIBMTR.
• Maintain transplant databases and organize study records that serve as the basis for paper and electronic CRFs.
• Continue to update training in the proper use of Forms Net, CIBMTR web‑based application and the National Marrow Donor Program (NMDP) forms.
• Track down long‑term follow‑up information on transplant patients who are no longer receiving active treatment.
• Ensure that source documents clearly supporting data reported are organized and readily accessible per regulatory review or sponsor requirements and site procedures.
• Communicate needed scheduling of participants on active treatment and in follow‑up as it relates to data collection at protocol‑defined time points and site procedures.
• Participate and communicate activities related to regulatory operations and compliance, including bi‑monthly reviews/audits of updates to protocols, completion of tracking tools, collection of documentation to support the Institutional Review Board (IRB) submissions and completion of forms for the IRB. Act as primary contact with the CIBMTR, any active research studies sponsor and the Bone Marrow Transplant program for all data issues, including query resolution, data clarification and regulatory support.
• Consult with other members of the transplant team as necessary, to resolve queries when needed, providing background and supporting data to facilitate resolution.
• Work with interdisciplinary teams. Communicate effectively with Study Sponsor and Bone Marrow Transplant program members.
• Demonstrate the ability to process data extraction, analysis and query resolution in a timely and accurate manner.
• Seek out required patient data by contacting other departments, hospitals, and physician offices to obtain medical records through utilization of communication and software skills.
• Maintain patient charts in an organized fashion for needed information for the transplant team, insurance companies, program information and to complete submission of data. Assure and improve quality aspects of the bone marrow transplant program. Work closely with the transplant team in preparation for accreditations not limited to the Foundation for the Accreditation of Cellular Therapy (FACT), National Marrow Donor Program (NMDP) Be The Match and CIBMTR.
• Participate in the retrieval and maintenance of patient records and ongoing review and audits, maintaining the high quality standards for the program.
• Review quality data at regular intervals, identifying areas of strength and improvement. Analyze the data and develop quality reports, quarterly reviews, identifying opportunities for publications, posters and papers to reflect on the quality data, focusing on continuous improvements of the clinical outcomes of transplant patients.
• Participate in quality management activities to improve the quality of the transplant program, following FACT guidelines and standards. Stay well‑informed of transplant and quality management developments through internal and external resources, such as CIBMTR network and form updates. Work with the Russell Institute for Research & Innovation (RIRI) directly to maintain tracking systems for all participants on clinical trials including screening, enrollment, follow‑up, Serious Adverse Event (SAE), and deviation logs.
• Conduct regular audits of a variety of research information, including SAEs, and other items as needed. Maintain records and files within the transplant department.
• Communicate with the RIRI to ensure that IRB submissions are complete and timely.
• Perform additional duties as assigned.