Transplant and Cellular Therapy Data Management Associateno,

Major Responsibilities:
Data Management responsibilities involve the collection and reporting of transplant patient clinical and outcomes data; and the collection and reporting of patient data for clinical trials, following established sponsor protocols and procedures.
1)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 in to the CIBMTR

2)Maintain transplant databases and organize study records that serve as the basis for paper and electronic CRFs.

3)Continue to update training in the proper use of FormsNet, CIBMTR web-based application and the National Marrow Donor Program (NMDP) forms.

4)Tracks down long-term follow-up information on transplant patients who are no longer receiving active treatment.

5)Ensure that source documents clearly supporting data reported are organized and readily accessible per regulatory review or sponsor requirements and site procedures.

6)Communicates 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.

7)Data Manager participates and communicates 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.

Acts 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
1)Consults with other members of the transplant team as necessary, to resolve queries when needed, providing background and supporting data to facilitate resolution.

2)Work with interdisciplinary teams. Communicates effectively with Study Sponsor and Bone marrow transplant program members.

3)Demonstrate the ability to process data extraction, analysis and query resolution in a timely and accurate manner.

4)Seeks out required patient data by contacting other departments, hospitals, and physician offices to obtain medical records through utilization of communication and software skills

5)Maintains patient charts in an organized fashion for needed information for transpalnt team, insurance companies, program information and to complete submission of data.

Assures and improve quality aspect of the bone marrow transplant program. Works 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.
1)Participates in the retrieval and maintenance of patient records and ongoing review and audits, maintaining the high quality standards for the program.

2)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

3)Participates in quality management activities to improve the quality of the transplant program, following FACT guidelines and standards. Responsible for staying well-informed of transplant and quality management developments through internal and external resources, such as CIBMTR network and forms updates.

Works 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
1)Conducts regular audits of a variety of research information, including SAEs, and other items as needed. Maintaining records and files within the transplant department.

2)RIRI to provide regulatory support for this work, therefore this position will communicate with the RIRI to ensure that IRB submissions are complete and timely.

3)Performs additional duties as assigned.

Education/Experience Required:
Associate degree or equivalent and 3+ years experience in health care setting and/or research

Knowledge, Skills & Abilities Required:
Proficient computer and internet skills. Type 50 -60 words per minute preferred. Able to utilize several soft-ware packages. Ability to create spread sheets, power point, posters. Have analytical skills and be able to interpret data. Be familiar with the tools and methodology needed for successful quality control. Basic comprehension of medical oncology.
N/A

Physical Requirements and Working Conditions:
Ability to travel throughout the LGH campus and to off campus offices as needed. Ability to act quickly to process adverse events Ability to work in fast paced environment with established time constraints. Ability to communicate in team meetings and up date data requirements. Ability to work efficiently within interdisciplinary teams
Lifting patient charts, notebooks.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.