Clinical Study and Regulatory Assistant
Core
Support clinical research operations for the HPB Oncology Research Group by managing data entry, regulatory compliance, and study logistics.
Role type
Clinical Study and Regulatory Assistant
Builds
Clinical research data sets and compliant study documentation
Domain
Healthcare / Oncology Research
Deliverable
dashboards & analysis
Required skills
Data entry, Regulatory compliance, Protocol deviation tracking, Supply management, Query resolution, Document management
Preferred skills
Clinical research experience, Knowledge of ICH/GCP guidelines, Electronic Data Capture (EDC) systems
Technologies
REDCap, Medidata
Responsibilities
Collect and verify clinical research data; Enter medical data into EDC systems; Track protocol deviations and SOP non-compliance; Coordinate study blood collection kits and supplies; Support participant compliance with study procedures; Resolve sponsor and internal data queries; Maintain essential study documents and ethics approvals; Create and update study trackers and operational tools; Coordinate study close-out activities.