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...