Job Description
Sr. CRA I (Sponsor dedicated) - Sao Paulo, Brazil Home Based
Senior Clinical Research Associate dedicated to sponsor activities; responsible for site qualifications, monitoring, and close‑out visits in both on‑site and remote settings.
Job Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management and close‑out visits in compliance with regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practice guidelines; evaluate site performance and provide recommendations.
- Verify informed consent procedures and document safety and data integrity issues at investigator sites.
- Conduct source document reviews, verify CRF data accuracy and completeness, and resolve queries within agreed timelines.
- Manage investigational product inventory, reconciliation, dispensing, and storage; ensure proper labeling, import, release, or return of IP.
- Review Investigator Site Files for accuracy and r...