Senior CRA – FSP

🕒 Outubro 29

🇲🇽 México – Remoto

⏰ Tempo Integral

🟠 Sênior

🧪 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

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 and coordinate clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor-specific procedures and guidelines • Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure subjects’ rights, well-being and data reliability • Maintain audit readiness and collaborative relationships with investigational sites • 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 data review, source data verification and CRF review • Assess investigational product through inventory and records review • Prepare monitoring reports and letters; escalate deficiencies and follow issues through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and issue/finding resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform report quality-control checks where required • Participate in investigator meetings • Identify potential investigators and initiate clinical trial sites • Ensure trial close-out and retrieval of trial materials • Ensure essential documents are complete and properly filed • Conduct on-site file reviews • Assist with project publications, tools, newsletters, trip report reviews and CRA team calls • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports, timesheets and other administrative tasks • Contribute to process-improvement initiatives and other project work

🎯 Requisitos

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Minimum of 3 years of completed on-site clinical monitoring experience • Minimum of 2 years of completed experience as the lead Clinical Research Associate (CRA) on Oncology and/or Hematology clinical trials • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills with medical personnel • Customer focus, listening skills and attention to detail • Effective interpersonal skills • Strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work in a team or independently • Proficient knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Ability to comply with sponsor/client/site requirements, including possible disclosure of vaccination status or other personal information • Ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home-office environments • Ability to use required personal protective equipment when exposed to biological fluids or infectious organisms

🏖️ Benefícios

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with global clinical research teams and leading pharmaceutical and biotech companies • Professional involvement in clinical trials across diverse sponsors and monitoring environments • Collaborative relationships with investigational sites and project teams

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