Clinical Research Data Abstraction; Remote, East and West Coast) Part time

Role:

• Review retrospective patient medical records to identify eligible study subjects.
• Abstract protocol-defined data elements from source documentation including progress notes, procedure reports, imaging reports, laboratory results, hospital records, and device-related records.
• Enter and reconcile data within study databases and electronic case report forms (eCRFs).
• Identify and document protocol-defined clinical events and outcomes.
• Perform quality control reviews to ensure completeness, consistency, and accuracy of abstracted data.
• Resolve data discrepancies and respond to data queries.
• Maintain compliance with study procedures, data privacy requirements, and applicable regulations.
• Collaborate with monitors, project management, and sponsor teams to support timely study execution.
• Participate in study-specific training and calibration activities to ensure consistency across abstractors.
• Support preparation of event packages and supporting documentation for clinical review or adjudication when applicable.

• Real-World Evidence (RWE) and Real-World Data (RWD) studies.
• Retrospective chart review and medical record abstraction.
• Medical device studies and/or cardiovascular studies (preferred but not required).
• Strong clinical documentation review and interpretation skills.