Clinical Research Associate II

MSD

. Independently manage clinical trial sites from initiation through close-out .

Posted 10/15/2026full-timeSão Paulo • BrazilJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing clinical trial sites, ensuring compliance with ICH-GCP and regulatory requirements, and maintaining high-quality documentation throughout the clinical trial lifecycle. Strong proficiency in conducting monitoring visits and building relationships with stakeholders to support study delivery.

Highest-signal resume keywords

Clinical Trial ManagementOn-Site Monitoring VisitsICH-GCP ComplianceMonitoring Visit ReportsStakeholder Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial ProcessesSite ManagementSource Document ReviewRisk Identification and ResolutionInspection-Ready RecordsCTMSETMFStudy Data Quality AssuranceAudit SupportTherapeutic Area Knowledge

Soft Skills

Strong CommunicationOrganization SkillsRelationship Building

Industry Keywords

CROPharmaceutical CompaniesClinical Trial PhasesRegulatory RequirementsStudy Documentation

About the role

Key responsibilities & impact

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, escalate, 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

Requirements

What you’ll need

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
Experience in CROs and/or pharmaceutical companies (preferred)
Experience supporting audits and inspections (preferred)
Experience across multiple therapeutic areas and clinical trial phases (preferred)

Benefits

Comp & perks

Inclusive and diverse workplace
Equal employment opportunities
No relocation required
No visa sponsorship required
Regular employee status