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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.
Job Responsibility:
Data Management responsibilities involve the collection and reporting of transplant patient clinical and outcomes data
the collection and reporting of patient data for clinical trials, following established sponsor protocols and procedures
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
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 FormsNet, CIBMTR web-based application and the National Marrow Donor Program (NMDP) forms
Tracks 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
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
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
Consults 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
Communicates 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
Seeks out required patient data by contacting other departments, hospitals, and physician offices to obtain medical records through utilization of communication and software skills
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
Participates 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
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
Conducts regular audits of a variety of research information, including SAEs, and other items as needed
Maintaining records and files within the transplant department
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
Performs additional duties as assigned
Requirements:
Associate degree or equivalent
3+ years experience in health care setting and/or research
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
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
What we offer:
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs