Clinical Research Associate I (CRA I) - São Paulo/SP

MSD; São Paulo; On-site; BRL 90,000 - 150,000; Full time

Job summary

Merck & Co., Inc. procura um(a) Clinical Research Associate (CRA) para apoiar sites de estudo clínico em todas as fases. O(a) profissional atuará como contato principal, gerando relações com investigadores, monitorando conformidade e qualidade de dados, e apoiando atividades de ativação de sites.

É exigido diploma na área de ciências da vida, experiência clínica e fluência em Português com inglês avançado. A posição envolve viagens para monitoramento no Brasil, com ambiente multicultural e

Qualifications

• Bacharelado em Ciências da Vida ou área relacionada com experiência clínica.
• Conhecimento de GCP/ICH, regulamentação local e documentos regulatórios.
• Experiência em monitoramento de sites, operações clínicas e gestão de registros.

Responsibilities

• Atuar como contato principal para os locais de pesquisa ao longo do ciclo do estudo.
• Conduzir monitoramento remoto e on-site conforme ICH-GCP e procedimentos.
• Realizar visitas de qualificação, iniciação, monitoramento e encerramento.
• Revisar documentação regulatória e manter registros atualizados.
• Apoiar ativação de sites e colaborar com equipes multifuncionais.
• Garantir qualidade de dados, conformidade e proteção de participantes.
• Identificar problemas de desempenho e oferecer ações corretivas.
• Manter informações em CTMS e eTMF; apoiar auditorias quando necessário.

Skills

Clinical Research

GCP/ICH

Site Management

Data Analysis

Regulatory Compliance

Education

Bacharel em Ciências da Vida ou área relacionada

Tools

CTMS

eTMF

EDC

MS Office

Job description

Job Description Join Our Team as a Clinical Research Associate (CRA)! Are you passionate about clinical research and committed to advancing healthcare? We are looking for a Clinical Research Associate (CRA) to support and manage clinical trial sites throughout all phases of the study lifecycle, ensuring compliance, data quality, and patient safety.

Key Responsibilities

• Serve as the primary contact for assigned research sites throughout the clinical study lifecycle.
• Build and maintain strong relationships with investigators and site staff.
• Conduct remote and on-site monitoring activities in compliance with ICH-GCP, local regulations, protocols, and company procedures.
• Perform site visits, including site qualification, initiation, monitoring, and close-out visits.
• Review and maintain study and regulatory documentation throughout study start-up, maintenance, and close-out.
• Support site activation activities and collaborate with cross-functional teams to achieve Site Ready status.
• Ensure data quality, protocol compliance, and protection of participant rights, safety, and well-being.
• Identify and elevate site performance, quality, or compliance issues, driving appropriate corrective actions.
• Maintain accurate documentation and study information in clinical systems such as CTMS and eTMF.
• Support audit, inspection, and co-monitoring activities when required.

Main Requirements

• Education: Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Biomedicine, or related healthcare/scientific discipline. Other degrees may be considered with relevant healthcare experience.
• Experience: Previous experience in clinical research, healthcare, site coordination, clinical operations, or related areas. Experience as a Clinical Trial Assistant (CTA), Research Coordinator, Research Nurse, or similar is highly valued.
• Languages: Fluent Portuguese and advanced English (written and spoken).
• Knowledge of clinical research processes, GCP/ICH guidelines, and local regulatory requirements.
• Understanding of clinical trial monitoring, site management, and regulatory documentation.
• Experience or familiarity with clinical systems such as CTMS, eTMF, EDC, and MS Office applications.
• Strong organizational, communication, and stakeholder management skills.
• Ability to prioritize multiple tasks, work independently, and manage competing deadlines.
• Problem-solving mindset with the ability to identify root causes and support CAPA implementation.
• Ability to work effectively in a multicultural and matrix environment.
• Willingness to travel for on-site monitoring visits as required.

Required Skills

• Accountability
• Accountability
• Adverse Event Report
• Clinical Evaluation Reports
• Clinical Reporting
• Clinical Research
• Clinical Research Methods
• Clinical Site Management
• Clinical Study Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Data Analysis
• Data Monitoring
• Document Management
• Electronic Trial Master File
• Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Investigations Training
• Key Stakeholder Relationships
• On Site Monitoring
• Protocol Adherence
• Protocol Development
• Regulatory Affairs Management
• Regulatory Audits
• Regulatory Compliance {+ 8 more}

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s):

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros.

Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado.