Senior Clinical Research Associate

Senior Clinical Research Associate - Detalhes da Vaga. ● The Senior Clinical Research Associate is responsible for the overall management and oversight of assigned clinical trial sites, including site identification, feasibility assessments, pre-study evaluations, study start-up, site initiation, patient recruitment, site monitoring, close-out activities, inspection readiness, and local regulatory and IRB/EC submissions. ● This role ensures clinical studies are conducted in accordance with study protocols, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and all applicable regulatory requirements while supporting the successful execution of clinical programs. ●Responsibilities:Oversee the successful start-up, monitoring, and execution of Phase IIV clinical studies at assigned investigative sites. ●Conduct clinical site management and monitoring activities in compliance with ICH-GCP guidelines, Standard Operating Procedures (SOPs), study protocols, applicable study plans, local regulations, and internal working procedures. ●Serve as the primary point of contact for assigned clinical sites throughout the entire study lifecycle, from site start-up through close-out. ●Coordinate monitoring schedules and ensure timely completion of site visits, data entry, and study milestones at assigned sites. ●Perform routine monitoring activities, including source data verification (SDV), to ensure data integrity, protocol compliance, and adherence to established study timelines. ●Build, maintain, and strengthen relationships with investigators and site personnel to promote effective communication, site engagement, and successful study execution. ●Qualifications:MUST be bilingual including 100% fluent in EnglishBachelors Degree in a Life Science discipline requiredBachelors Degree in Nursing or RN a plusMinimum 3 years of direct site monitoring experience requiredDetailed understanding of all aspects of clinical site monitoring and understanding of overall drug development. ●. Requisitos para participar do processo. ● . O que oferecemos.