Clinical Research Associate II (CRA II) - São Paulo, Brasil
Core
Primary site contact for clinical research studies, ensuring protocol compliance and data quality across all trial phases.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data and regulatory compliance
Domain
Healthcare / Clinical Research
Required skills
On-site monitoring, ICH-GCP compliance, Source document review, Risk identification, Study documentation, Cross-functional collaboration
Preferred skills
CRO/pharma experience, Audit/inspection support, Multi-therapeutic area experience
Technologies
CTMS, eTMF
Responsibilities
Manage clinical trial sites from initiation to close-out, Conduct on-site monitoring visits (SQV, SIV, Routine, Close-Out), Ensure compliance with protocols and local regulations, Review source documents and study data, Identify and resolve site-related issues, Prepare monitoring visit reports, Maintain inspection-ready records, Build relationships with investigators
Seniority
Mid-Senior, hands-on IC