Clinical Research Associate II

2 days ago

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501 - 1000

Description

• Conduct site visits and function as site manager • Monitor data quality and patient safety • Complete aspects of the clinical monitoring process in accordance with ICH-GCP guidelines • Develop collaborative relationships with investigative sites • Ensure timely delivery of study milestones • Provide audit/inspection preparation support

Requirements

• Fluent in English and Portuguese • BS/BA in a relevant scientific discipline • Minimum of 2+ years of relevant Clinical Operations experience • Minimum of 1+ years of monitoring experience • Experience in global oncology trials preferred • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines • Excellent communication and interpersonal skills • Excellent organizational skills and ability to prioritize and multi-task • Provides site level management for established protocols and portfolio under general supervision • Provides mentoring/support to CRAs for CRA related topics