Assistant CRA

🕒 Julho 28

🇲🇽 México – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👻 Score fantasma 32%

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

• Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned. • Completes and documents study-specific training. • Orients and trains on any study-specific systems. • Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project. • Supports to customize Site ICF with site contact details, as needed. • Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments. • Verifies document collection and RCR submission status; updates site EDL and verifies site information. • Reviews patient facing materials and review translations, as directed. • Supports site staff with the vendor related qualification process, where applicable. • Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study. • Provides support to follow-up on site staff training, as applicable. • Coordinates and supports logistics for IM attendance, as directed. • Supports maintenance of vendor trackers, as directed. • Coordinates study/site supply management during pre-activation and subsequent course of the study. • Supports Essential Document collection, review and updating in systems, as applicable. • Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed. • Supports ongoing remote review of centralized monitoring tools, as directed. • Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period. • Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable. • Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed. • May perform other assigned site management tasks, as directed by CRA and as per Task Matrix. • May perform a specific role profile for FSP opportunities according to Client requests. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

🎯 Requisitos

• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). • Basic medical/therapeutic area knowledge and understanding of medical terminology. • Ability to attain and maintain a 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, with proven ability to handle multiple tasks efficiently and effectively. • Proven flexibility and adaptability. • Ability to work in a team or independently, as required. • Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving. • Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable. • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards. • Excellent English language and grammar skills.

🏖️ Benefícios

• Flexible work arrangements • Professional development opportunities