Assistant CRA – FSP

🕒 Setembro 14

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👻 Score fantasma 15%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

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

• Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead • Support site preparedness and the monitoring process • Assist with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines • Complete study and site management activities defined in the task matrix • Complete and document study-specific training and orient to study-specific systems • Provide in-house support during pre-study assessments and assessment waivers • Customize site ICFs with site contact details as needed • Perform remote review of EMR/EHR checklists and support applicable assessments • Verify document collection and RCR submission status; update site EDL and site information • Review patient-facing materials and translations • Support vendor-related qualification processes for site staff • Support system access requests, grants, and revocations for site staff • Follow up on site staff training • Coordinate logistics for IM attendance • Maintain vendor trackers • Coordinate study/site supply management • Support essential document collection, review, and system updates • Follow up on missing vendor data, including ECGs, lab samples, and e-diaries • Support ongoing remote review of centralized monitoring tools • Support site payment processes, system updates, reconciliations, and invoice follow-up • Perform reconciliation tasks involving CRF and query status, deviations, SAEs, and safety reports • Verify document collection status and drive action on missing, incomplete, or expired documents • Perform other assigned site management tasks as directed by the CRA and task matrix • Complete administrative tasks, including expense reports and timesheets • Occasional travel to clinics or hospitals may be required

🎯 Requisitos

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 2 years • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Previous oncology clinical trial management experience is highly valued • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and company procedural documents • Effective oral and written communication skills • Excellent interpersonal and customer service skills • Good organizational and time management skills and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Flexibility and adaptability • Ability to work independently or in a team • Well-developed critical thinking, root cause analysis, and problem-solving skills • Proficient computer skills and good knowledge of MS Office • Ability to learn and use appropriate software and modern technology • Ability to extract pertinent information from study documents, electronic study data systems, CTMS, and dashboards • Excellent English language and grammar skills

🏖️ Benefícios

• Fully remote work arrangement • Standard Monday–Friday work schedule