Clinical Research Associate II - Madrid
Core
Conducting routine and closeout monitoring of clinical trial sites to ensure data integrity, patient safety, and regulatory compliance.
Role type
Clinical Research Associate II (Oncology/Respiratory)
Builds
Clinical trial data and site management for oncology early phase and respiratory studies
Domain
Clinical Research / Oncology / Respiratory
Deliverable
client delivery
Required skills
Clinical site monitoring, Source document review, Case Report Form (CRF) review, Query generation and resolution, Serious Adverse Event (SAE) tracking, Regulatory compliance (ICH GCP), Site feasibility assessment, Vendor liaison, Registry management, EC submission preparation
Preferred skills
None stated
Technologies
Fortrea data management systems, Client data management systems
Responsibilities
Conduct routine and closeout monitoring of clinical sites, Ensure protection of study patients via informed consent verification, Monitor data for missing or implausible entries, Track and follow up on Serious Adverse Events, Independently perform CRF review and query resolution, Prepare accurate trip reports, Assist in managing investigator site budgets, Undertake feasibility work, Participate in Quality Control Visits
Seniority
Mid-level, hands-on IC