Senior Clinical Research Associate

🕒 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

• Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage clinical monitoring and site management processes and required documentation • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Apply risk-based monitoring, 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 inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and findings resolution • Provide trial status tracking and progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and reports • Participate in investigator meetings and identify qualified investigative sites • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Maintain essential documents and conduct on-site file reviews • Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls • Facilitate communication among investigative sites, client company personnel, and the PPD project team • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to project work and process improvement initiatives • Support mentoring, training, and development of junior clinical team members

🎯 Requisitos

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification • Considerable clinical research monitoring experience comparable to 5+ years • Demonstrated high level of expertise in all aspects of clinical monitoring • Expert clinical monitoring skills • Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents • Excellent critical thinking, root cause analysis and problem-solving skills • Proficient in Risk Based Monitoring concepts and processes • Ability to evaluate medical research data and proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal skills • Excellent organizational and time management skills • Strong attention to detail • Ability to remain flexible and adaptable • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to work in office, laboratory, clinical, and/or home office environments • Ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work with required personal protective equipment and potential exposure to biological fluids/infectious organisms • Ability to work upright and/or stationary for 6–8 hours per day • Ability to lift and carry up to 15–20 lbs • Regular and consistent attendance

🏖️ Benefícios

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture • Accessibility assistance or accommodation during the job application process

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