Senior Clinical Research Associate (Brazil)
Core
Senior Clinical Research Associate managing complex clinical trials across Brazil, ensuring patient safety, data quality, and regulatory compliance.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial operations and data integrity for biopharma studies
Domain
Clinical Research / Biopharma
Required skills
Clinical trial monitoring, site management, regulatory compliance (GCP/ICH), protocol deviation management, adverse event reporting, data review, investigator relations, travel management
Preferred skills
Rare disease monitoring, EDC/EHR experience, oncology experience, contract negotiation, mentorship
Technologies
EDC systems, TMF, ISF, remote monitoring tools
Responsibilities
Conduct on-site and remote monitoring visits (pre-study, initiation, routine, close-out); manage site start-up including feasibility, recruitment, and regulatory submissions; verify informed consent processes; review clinical data and resolve queries; manage investigational product inventory and dispensing; mentor junior staff; prepare monitoring reports and documentation; attend investigator and sponsor meetings.
Seniority
Senior, hands-on IC with mentorship responsibilities
