Research Data Specialist - GI Oncology Clinical Trials

Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. They are seeking a Research Data Specialist to support the GI Oncology Clinical Research Program in data collection, management, and quality assurance for 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