Clinical Research Associate II (CRA II) - São Paulo, Brasil
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Independently manage clinical trial sites from initiation through close-out, conducting on-site monitoring visits including SQV, SIV, Routine Monitoring, and Close-Out Visits. Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations by reviewing source documents and study data to guarantee quality and patient safety. Identify, escalate, and resolve site-related issues while preparing monitoring visit reports and maintaining inspection-ready records in CTMS, eTMF, and other clinical systems. Build effective relationships with investigators and site personnel, partnering with cross-functional teams to support study delivery and site performance.
Required Qualifications
- Bachelor's degree
- Experience independently conducting on-site monitoring visits at hospitals and research centers
- Experience managing sites throughout the clinical trial lifecycle
- Experience preparing monitoring visit reports and maintaining clinical trial documentation
- Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements
- Advanced English proficiency (written and spoken)
- Strong communication, organization, and stakeholder management skills
- 75% travel
- Valid Driving License
Desired Qualifications
- Experience in CROs and/or pharmaceutical companies
- Experience supporting audits and inspections
- Experience across multiple therapeutic areas and clinical trial phases
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