Senior Clinical Research Associate
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Conduct site visits including PSSV, SIV, IMV, and COV to assess protocol and regulatory compliance while monitoring data quality and patient safety. Build collaborative relationships with investigative sites and study vendors, providing protocol training and overseeing site performance through enrollment metrics and CRF data tracking. Serve as a mentor to less experienced CRAs, reconcile Serious Adverse Events, and support audit/inspection preparation. Travel up to 70% to support study milestones and regional investigator meetings. Assist with database analyses and closeout activities in accordance with ICH-GCP guidelines.
Required Qualifications
- Fluent English (writing and speaking)
- BS/BA in a relevant scientific discipline
- Minimum of 3+ years of relevant Clinical Operations experience
- Minimum of 2+ years of monitoring experience
- Up to 70% travel
- Fluent English is Required
Desired Qualifications
- Pharmaceutical/Biotech Industry experience
- Hematology experience
- Oncology experience
- Experience in global oncology trials
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