Clinical Trial Manager

Há 2 dias


Belo Horizonte MG, Brasil beBeeResearch Tempo inteiro

Senior Research Associate Role Seeking a detail-oriented and experienced Senior Research Associate to oversee the management of Phase 2 clinical trials for seizures. Key Responsibilities: Site Management and Oversight: Conduct site qualifications, initiations, interim monitoring, and close-out visits to ensure protocol adherence and regulatory compliance. Verify accurate data collection and reporting through quality checks. Assess site performance, identifying areas for improvement and providing corrective actions when necessary. Regulatory Compliance and Safety: Ensure compliance with regulatory requirements and verify informed consent documents are up-to-date. Collaborate with regulatory teams to facilitate timely submissions and approvals. Data Validation and Management: Monitor adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities for accurate documentation in electronic systems. Validate source data, resolve discrepancies, and ensure timely documentation of clinical trial data. Communication and Collaboration: Build relationships with investigators and site staff through effective communication. Provide training on study protocols, procedures, and GCP compliance to site personnel.



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