Senior Clinical Research Associate

🕒 Outubro 20

🇲🇽 México – Remoto

⏰ Tempo Integral

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

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.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

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 and coordinate clinical monitoring and site management activities • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required clinical trial documentation and sponsor procedures • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Build collaborative relationships with investigational sites and client personnel • Support project managers and clinical team managers, taking a lead role when required • Mentor, train, and contribute to developing junior clinical team members • Monitor investigator sites using a risk-based monitoring approach • Perform root cause analysis and identify corrective/preventive actions • Ensure data accuracy through SDR, SDV, and CRF review • Assess investigational product inventory and records • Prepare timely reports and letters documenting observations • Escalate deficiencies and track issues through resolution • Maintain contact with sites between monitoring visits • Track trial status and provide progress updates to the Clinical Team Manager • Update clinical trial systems, including CTMS, and perform report quality checks • Participate in investigator meetings and identify qualified investigators and sites • Initiate clinical trial sites and ensure regulatory and ICH-GCP compliance • Ensure trial closeout and retrieval of trial materials • Review 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, clients, and project teams • Respond to company, client, and regulatory audits and inspections • Complete expense reports, timesheets, and other administrative tasks • Contribute to process improvement initiatives

🎯 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 • Proficient knowledge of medical terminology • Excellent oral and written communication skills • Ability to maintain customer focus • Excellent interpersonal, organizational and time management skills • Strong attention to detail • Flexibility and adaptability • Effective presentation skills • Good digital literacy and proficient knowledge of Microsoft Office • Ability to work in an office, laboratory, clinical, and/or home office environment • Frequent travel to site locations, generally 60–80%, with possible extended overnight stays • Ability to work upright and/or stationary for 6–8 hours per day • Frequent mobility • 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