Research Data Specialist - Breast Oncology Cohort Studies Program

Research Data Specialist - Breast Oncology Cohort Studies Program Responsibilities

The Research Data Specialist (RDS) will support the Breast Oncology Cohort Studies program under the auspices of the Principal Investigators, Director, and Research Manager, in the areas of clinical data collection and collation of biospecimens - specifically related to patients with germline mutations in the Department of Breast Oncology. Duties include examining, synthesizing, and evaluating medical records; abstracting and recording pertinent medical information;

and organizing and collating biospecimens collected within cohort studies. The position works with investigators focused on germline mutations (e.g., BRCA1/2). The RDS will also review and abstract medical records for patients, entering clinical data into cohort study databases, ensuring accurate entry of biospecimens into tracking systems, retrieve archival tissue samples at outside institutions for translational studies, coordinate collection, processing, organization, and storage of biological specimens (tissue, blood, stool) and maintain specimen tracking systems in ca Tissue, REDCap, and other study databases, organize samples for translational studies by completing manifests, labeling, and documenting tasks, coordinate linkage of clinical annotation with biospecimens, complete essential regulatory documentation (protocol, material transfer agreement, data use agreement) for sample access, use, and transfer to outside collaborators, and work remotely in a New England State (MA, ME, NH, CT, RI, VT) with hybrid onsite days.

• Review and abstract medical records for patients, entering clinical data into cohort study databases and ensuring accurate entry of biospecimens into tracking systems.
• Retrieve archival tissue samples at outside institutions for translational studies.
• Coordinate collection, processing, organization, and storage of biological specimens (tissue, blood, stool) and maintain specimen tracking systems in ca Tissue, REDCap, and other study databases.
• Organize samples for translational studies by completing manifests, labeling, and documenting tasks.
• Coordinate linkage of clinical annotation with biospecimens.
• Complete essential regulatory documentation (protocol, material transfer agreement, data use agreement) for sample access, use, and transfer to outside collaborators.
• Work remotely in a New England State (MA, ME, NH, CT, RI, VT) with hybrid onsite days.

• Review and abstract medical records for research patients on trials.
• Enter identified clinical data points in the corresponding database.
• Ensure data is entered within outlined timelines for each trial.
• Assist research teams with development, testing, and implementation of Case Report Forms for PI-initiated trials.

• Evaluate and track eligibility of all patients seen in the clinic for inclusion.
• Assist or be responsible for consenting eligible patients in clinic.
• Maintain ongoing communications with Information Services, physicians, and staff.
• Review and abstract medical records, entering data into CRIS.
• Access patient demographic and clinical information from clinical systems and enter into database.
• Review data for quality and completeness using reporting software.
• Collaborate with principal investigators, IS staff, and clinic staff in continued development of CRIS.
• Assist in creation of data reports for quality assurance.
• Coordinate collection, processing, organization, and storage of biological specimens, maintain electronic specimen tracking systems (STIP) and laboratory binders.
• May be responsible for IRB and regulatory submissions and maintenance of regulatory files.

• Support clinical programs with outcomes data collection, reporting, analysis, and audits.
• Ensure timely reporting to internal and external outcomes data repositories.
• Ensure case management documentation in patient medical records and other information management systems.
• Perform QA and QC procedures to ensure optimal data reporting.
• Develop knowledge of specialized data sources for outcomes reporting, reaching out to offsite providers for outside…