Clinical Research Associate I

🕒 3 dias atrás

🇨🇴 Colômbia – Remoto

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🧪 Pesquisa Clínica

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.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

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

Biotechnology • Pharmaceuticals • Healthcare

A Thermo Fisher Scientific é líder mundial em soluções para a ciência, com a missão declarada de ajudar seus clientes a tornar o mundo mais saudável, limpo e seguro. A empresa oferece um amplo portfólio de instrumentos de laboratório, tecnologias analíticas, diagnósticos, consumíveis, software e serviços que apoiam a pesquisa em ciências da vida, testes analíticos, diagnósticos clínicos e o desenvolvimento e a fabricação de terapias. Suas operações e ofertas, conforme descrito em seu site e em suas notícias, incluem tecnologias avançadas de imaging e microscópios eletrônicos, sistemas de cromatografia e espectrometria de massas, testes genéticos e clínicos, automação de laboratórios e ferramentas de IA, bioprocessamento e serviços de desenvolvimento e fabricação sob contrato (CDMO). Entre as marcas citadas estão Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon e PPD. A Thermo Fisher informa receita anual superior a US$ 45 bilhões e destaca sua responsabilidade social corporativa, além de programas ambientais e comunitários junto a seus produtos e serviços científicos.

Descrição

• Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify site process failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and case report form review • Assess investigational product through physical inventory and records review • Document observations in reports and letters using approved business-writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution and timely data recording • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Help identify potential investigators and initiate clinical trial sites in compliance with protocols, regulations and ICH-GCP obligations • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews according to project specifications • Provide trial status tracking and progress updates • Keep study systems complete, accurate and updated, including Clinical Trial Management Systems • Facilitate communication between investigative sites, the client company and internal project teams • Respond to company, client and regulatory requirements, audits and inspections • Complete administrative tasks such as expense reports and timesheets • Assist with project publications and tools, share suggestions, and contribute to process-improvement initiatives

🎯 Requisitos

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent formal academic/vocational qualification • Minimal clinical monitoring experience comparable to 2 years in a clinical environment • Experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology • Ability to conduct risk-based monitoring and apply root cause analysis, critical thinking and problem-solving skills • Knowledge of ICH-GCP, applicable regulations, clinical trial protocols and monitoring plans • Ability to use clinical trial systems, including Clinical Trial Management Systems • Ability to comply with sponsor, client and site requirements, including disclosure of vaccination status or other personal information when required • Ability to travel frequently, generally 60–80%, with a stated travel requirement higher than 75% • Ability to make frequent drives to site locations and undertake extended overnight stays • Ability to work with potential exposure to biological fluids and infectious organisms • Ability to work in fluctuating and/or extreme temperatures on rare occasions

🏖️ Benefícios

• Fully remote work mode • Standard Monday–Friday work schedule • Work performed in office/laboratory/clinical and/or home office environments • Personal protective equipment provided/required, including protective eyewear, garments and gloves

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