Time as Reported Grade 052 SMH Hematology/Oncology
Gathers information, analyzes and interprets data, disseminates information; helps formulate goals, protocols and information gathering methods.
- Under general direction within policy guidelines and protocols:
- Data management, collection, scanning, review, querying, updating, filing, and reporting of this data. Collects data by the use of questionnaires, interviews, reports and searches of existing journals, etc.
- Acts as liaison with CIBMTR to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator and Sub Investigators, and to ensure case report forms are complete, accurate and available for review. Maintains accurate and up-to-date study subject documents.
- Communicates with sponsor to clarify data queries.
- Performs ongoing quality assurance procedures, in order to ensure database integrity and that any data errors are identified quickly and corrected.
- Prepares for, participates in and serves as liaison for scheduled monitoring visits and audits conducted by the BMT Program and external agencies..
- Maintains records and conducts correspondence with a variety of agencies and officials that provide a source of information.
- May perform a large number of computer search strategies.
- Prepares reports and recommendations based upon analysis of information gathered.
- Reviews retrieved information for pertinence to the project.
- Creates reports for the BMT program and initiates quality reports to deliver to the BMT Quality Program.
- Meets with project participants to help formulate project goals and determine protocols and information gathering methods.
- May assist in design, development and programming of systems needed to meet optimum data presentation goals.
- Assists with data analysis and preparation of materials on request.
- Prepares and collates patient study information, status reports and updates as necessary for reporting on progress of patients undergoing Cellular Therapy in order to accomplish a timely completion.
- Collaborates with study physicians, and BMT staff in all phases of data collection for patients receiving Cellular Therapy. Disseminates information to team members, and external agencies including the Center for International Blood and Marrow Transplant Research (CIBMTR). Develops, documents and implements data management processes and ensures compliance with all applicable regulatory and departmental SOPs, regulations and guidelines.
- Collects clinical data during all phases of care, completes required report forms.
- Reviews and collects patient data for team projects.
- Assists with data collection for long-term projects.
- Maintain REDCap and Stem Soft databases as appropriate for BMT data
- Reviews work of Information Analyst I or others performing similar work, and supervises clerical staff and field work aides.
Bachelor's degree with major course work in social or technical field and some graduate level course work in that field (or library science or information science), and 1-2 years experience in the analysis and dissemination of information; or an equivalent combination of education and experience. Knowledge of programming and statistical programming packages would be helpful.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled