Clinical Research Associate

🕒 Julho 31

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🧪 Pesquisa Clínica

👻 Score fantasma 29%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.

🎯 Requisitos

• Bachelor's degree in a life sciences related field • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor) • Effective clinical monitoring skills • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manages Risk Based Monitoring concepts and processes • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel • Ability to maintain customer focus through the utilization of good listening skills, attention to detailand the ability to perceive customers’ underlying issues • Ability to work in a team or independently as required • Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software

🏖️ Benefícios

• Flexible work arrangements • Professional development

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