Research Data Specialist - Breast Oncology Clinical Trials

Dana-Farber Cancer Institute is a leader in life-changing breakthroughs in cancer research and patient care. The Research Data Specialist will support the Breast Oncology clinical research program by managing data collection, ensuring data quality, and collaborating with research teams to facilitate clinical trials.

Responsibilities:

• Responsible for reviewing and abstracting the medical records for research patients on trials they are assigned
• Entering identified clinical data points in the corresponding database
• Ensuring that data is entered within the outlined timelines for each trial
• Assisting research teams with the development, testing and implementation of Case Reports Forms for PI-Initiated clinical trials
• Evaluating and tracking the eligibility of all patients seen in the clinic for inclusion in the study
• May assist or be responsible for consenting eligible patients in clinic
• Maintaining on-going communications with Information Services and physicians and staff for data collection needs
• Reviewing and abstracting the medical records for patients
• Entering the clinical data into the Clinical Research Information Systems (CRIS)
• Accessing patient demographic and clinical information from the clinical systems
• Entering information into the database
• Reviewing data for quality and completeness using reporting software
• Collaborating with principal investigators, IS staff, and clinic staff in the continued development of the CRIS system
• Assist principal investigators and staff in the creation of data reports for quality assurance measures
• Coordinates the collection, processing, organization, and storage of biological specimens including maintenance of electronic specimen tracking systems (STIP) and laboratory binders
• May be responsible for IRB and regulatory submissions and maintenance of regulatory files
• Support the clinical programs with outcomes data collection, reporting, analysis and audits
• Ensures timely reporting to internal and external outcomes data repositories, including national repositories when required by regulatory requirements and U.S. law
• Ensure case management documentation in patient medical records and other information management systems as assigned to support clinical program clinical care
• Perform QA and QC procedures to ensure optimal data reporting as assigned
• Develop knowledge of specialized data sources specific to outcomes data reporting, including routine reaching out to offsite providers to obtain information from medical records at outside sites of care

Requirements:

• Excellent organizational and communication skills required
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts
• Must be detail oriented
• Ability to effectively manage time and prioritize workload
• Must practice discretion and always adhere to institutional confidentiality guidelines
• Must have computer skills including the use of Microsoft Office
• The position requires a bachelor's degree or 1 year of experience as a Dana-Farber Associate Research Data Specialist
• Experience of 0-1 years in a medical, scientific research, or technology-oriented business environment is preferred