Senior CRA – Level I

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/4/2026full-timeRemote • BrazilSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP guidelines and applicable regulations while maintaining data accuracy and integrity. Proficient in risk-based monitoring, critical thinking, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH GCP ComplianceRisk Based MonitoringCritical ThinkingEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProtocol ComplianceData VerificationRoot Cause AnalysisSource Document ReviewCase Report Form ReviewInventory ReviewQuality Control ChecksProject PublicationsMonitoring Plans

Soft Skills

Attention to DetailInterpersonal SkillsOrganizational SkillsTime ManagementFlexibility

Tools & Technologies

CTMSMicrosoft Office

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Infectious DiseaseRespiratory StudiesOphthalmology StudiesOncology StudiesClinical Trials

About the role

Key responsibilities & impact

Perform and coordinate clinical monitoring and site management activities
Conduct remote and on-site visits to assess protocol and regulatory compliance
Manage sponsor procedures, guidelines and monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Protect subjects' rights and well-being and ensure data reliability
Maintain audit readiness and collaborative relationships with investigational sites
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis, critical thinking and problem-solving to identify site-process failures and corrective/preventive actions
Ensure data accuracy through source document review, source data verification and case report form review
Assess investigational products through inventory and records review
Prepare timely reports and letters documenting observations
Escalate deficiencies and follow issues through resolution
Maintain contact with investigative sites between monitoring visits
Conduct monitoring tasks according to approved monitoring plans
Participate in investigator payment processes
Track trial status and provide progress updates to the Clinical Team Manager
Update clinical study systems, including CTMS, and perform required quality-control checks
Participate in investigator meetings and identify potential investigators
Initiate clinical trial sites and support trial closeout and retrieval of materials
Ensure essential documents are complete and conduct on-site file reviews
Assist with project publications, tools and other study tasks
Facilitate communication among investigative sites, the client company and the PPD project team
Respond to company, client and regulatory requirements, audits and inspections
Complete expense reports, timesheets and other administrative tasks
Contribute to project work and process-improvement initiatives

Requirements

What you’ll need

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Minimum of 3 years of completed on-site clinical monitoring experience
Experience in infectious disease (pneumonia), respiratory, ophthalmology and oncology clinical studies is preferred
Effective clinical monitoring skills
Understanding of medical/therapeutic area knowledge and medical terminology
Understanding and demonstrated application 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
Effective oral and written communication skills
Ability to communicate effectively with medical personnel
Customer focus, listening skills and attention to detail
Effective interpersonal, organizational and time management skills
Flexibility and adaptability
Ability to work independently and in a team
Proficiency in Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to comply with sponsor/client/site requirements, including possible vaccination-status or other personal-information disclosures
Ability to travel frequently, generally 60–80%, including extended overnight stays
Ability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms

Benefits

Comp & perks

Fully remote work arrangement
Full-time employment
Standard Monday–Friday work schedule
Frequent travel expenses likely associated with site visits
Professional development through participation in project publications, tools, process-improvement initiatives, and team calls