Clinical Research Associate II (CRA II) - São Paulo, Brasil

Merck Gruppe - MSD Sharp & Dohme; São Paulo; Hybrid; BRL 120,000 - 170,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in São Paulo, Brazil is seeking a Clinical Research Associate II to oversee on-site monitoring across all trial phases. You will ensure adherence to protocols, ICH-GCP, and regulatory requirements while maintaining high-quality data and patient safety.

The role emphasizes building strong site relationships, coordinating with investigators and cross-functional teams, and contributing to continuous process improvement in clinical research operations.

Qualifications

• Bachelor's degree in a related field.
• Experience conducting on-site monitoring visits at hospitals or research centers.
• Strong knowledge of ICH-GCP, trial processes, and regulatory requirements.
• Advanced English proficiency.

Responsibilities

• Independently manage clinical trial sites from initiation through close-out.
• Conduct on-site monitoring visits (SQV, SIV, Routine Monitoring, Close-Out).
• Ensure protocol compliance with ICH-GCP and local regulations.
• Review source documents and study data for quality and patient safety.
• Maintain inspection-ready records in CTMS and eTMF.
• Collaborate with investigators and cross-functional teams to support study delivery.

Skills

On-site monitoring

ICH-GCP knowledge

Advanced English

Stakeholder management

Regulatory compliance

Education

Bachelor's degree

Tools

CTMS

eTMF

Job description

Job Description

Are you passionate about clinical research and eager to make a significant impact in the healthcare industry? We are looking for a dedicated Clinical Research Associate II to join our team. In this role, you will be the primary site contact throughout all phases of clinical research studies, ensuring compliance with regulations and contributing to the success of our clinical trials. If you enjoy working with data and technical information, this is the perfect opportunity for you!

As a Clinical Research Associate II, you will play a crucial role in developing and maintaining strong relationships with study sites, facilitating communication, and ensuring that our research protocols are executed effectively. You will have the chance to contribute to the continuous improvement of our clinical research processes.

Key Responsibilities

• Independently manage clinical trial sites from initiation through close-out.
• Conduct on-site monitoring visits, including SQV, SIV, Routine Monitoring, and Close-Out Visits.
• Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations.
• Review source documents and study data to ensure quality and patient safety.
• Identify, elevate, and resolve site-related issues and risks.
• Prepare monitoring visit reports and maintain accurate study documentation.
• Maintain inspection-ready records in CTMS, eTMF, and other clinical systems.
• Build effective relationships with investigators and site personnel.
• Partner with cross-functional teams to support study delivery and site performance.

Qualifications

• Bachelor's degree
• Experience independently conducting on-site monitoring visits at hospitals and research centers.
• Experience managing sites throughout the clinical trial lifecycle.
• Experience preparing monitoring visit reports and maintaining clinical trial documentation.
• Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
• Advanced English proficiency (written and spoken).
• Strong communication, organization, and stakeholder management skills.

Preferred

• Experience in CROs and/or pharmaceutical companies.
• Experience supporting audits and inspections.
• Experience across multiple therapeutic areas and clinical trial phases.

#ClinicalTrialsBR

"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."

Additional location(s) Compensation Information:

Required Skills: Accountability, Accountability, Adaptability, Adverse Event Reporting System, Adverse Events, Clinical Development, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Incident Reporting, On Site Monitoring, Pharmacovigilance, Protocol Adherence, Regulatory Compliance, Regulatory Documents, Regulatory Research, Research Protocols, Serious Adverse Event Reporting {+ 4 more}

Preferred Skills:

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 75%

Flexible Work Arrangements: Remote

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a