Clinical Research Associate II

🕒 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

• Perform and coordinate clinical monitoring and site management activities • Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance • Manage clinical trial procedures, sponsor guidelines and monitoring environments • Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking and problem-solving to identify failures and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies to clinical management • Maintain contact with investigative sites between monitoring visits and follow issues through resolution • Participate in investigator payments, meetings and site identification • Initiate clinical trial sites and make recommendations regarding site qualification • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status tracking and progress updates to the Clinical Team Manager • Update clinical trial management systems according to study conventions • Facilitate communication among investigative sites, the client company and the project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications and tools and contribute to process improvement initiatives

🎯 Requisitos

• Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills, including communication with medical personnel • Customer focus, listening skills and attention to detail • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently or as part of a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home office environments • Ability to use required personal protective equipment and work around biological fluids and potentially infectious organisms

🏖️ Benefícios

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with a global team and leading pharmaceutical and biotech companies • Professional exposure to clinical trials across multiple countries and therapeutic areas

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