Renal Research Nurse / Clinical Research Coordinator - clinical trial data collection & CRF/EDC documentation (Visionary, ALXN2050, ACHIEVE, Dimension KD, OPUS-2, ALXN1920-PMN201, Biohaven, etc.)
Coordinated clinical trial data collection and verification for multiple Phase II/III renal studies, including screening, consenting, enrolment, and follow-up documentation. Managed quality assurance activities for collected clinical data using CRFs and Electronic Data Capture workflows to ensure completeness and data integrity. Supported monitoring, audits, and inspections by keeping study documentation accurate and inspection-ready across active trials. • Collected, recorded, and verified participant clinical data using Case Report Forms (CRFs). • Maintained Trial Master File (TMF) documentation and site files for ICH-GCP compliant study conduct. • Documented and reported adverse events (AEs/SAEs) according to GCP and organizational safety procedures. • Assisted monitoring visits by providing required documentation for audit/inspection readiness.