communication skills. Experience in cardiovascular studies and hands‑on familiarity with EDC entry, query resolution, prescreening... Perform EDC data entry and query resolution in a timely and accurate manner. Review patient charts and records from the site...
' visit per day and leave with no source documentation and EDC tasks incomplete. â— How to build your clinical research...
: Knowledge of clinical research operations, study data management, and electronic data capture (EDC) systems. General...
) Working knowledge of GCP (ICH E6), ISO 14155, and applicable FDA regulations Experience with electronic data capture (EDC...
, EDC platforms, and internal tracking tools Support day-to-day study operations and visit logistics Liaise...
protocol for entrance into study. Ensures data from source is entered in EDC per Sponsor contract expectations if not sooner...
.* Responsibilities Collect and enter data into the Electronic Data Capture (EDC) system Resolve queries related to the clinical trial... of 2 years of experience in EDC data entry Training in HIPAA and Good Clinical Practice (GCP) Experience working...
, and continuing review best practices · Safety reporting workflows (SAE/SUSAR notifications and timelines) · Source, EDC, and CTMS... creation, and ensure same-day EDC entry and reconciliation. 8. Communication: Serve as regulatory point of contact...
Vendor oversight and partnership management Problem solving, critical thinking and decision making Knowledge of EDC...
Informatica Intelligent Data Management Cloud (IDMC), Enterprise Data Catalog (EDC), and related tools to ensure data transparency...