Clinical Research Associate I

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/4/2026full-timeBrazilJuniorMid-LevelWebsite

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 regulatory requirements. Proficient in risk-based monitoring, data accuracy verification, and effective communication with investigative sites and stakeholders.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH GCP KnowledgeRisk Based MonitoringMedical Terminology ProficiencyData Accuracy Verification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Documentation ManagementSource Data ReviewRoot Cause AnalysisCase Report Form ReviewTrial Close-Out ProceduresInvestigator Site AssessmentRegulatory ComplianceClinical ResearchMedical ResearchHealth Care Knowledge

Soft Skills

Good Oral CommunicationGood Written CommunicationInterpersonal SkillsAttention to DetailOrganizational Skills

Tools & Technologies

CTMSMicrosoft Office

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsMedical TerminologyHealth SciencesRegulatory RequirementsSOPs

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 required clinical trial documentation and sponsor/monitoring procedures
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
Ensure subject rights, well-being, data reliability, and audit readiness
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis and corrective/preventive actions to resolve site process failures
Ensure data accuracy through Source Data Review, Source Data Verification, and Case Report Form 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
Conduct monitoring tasks according to the approved monitoring plan
Participate in investigator payments and investigator meetings
Identify potential investigators and initiate clinical trial sites
Perform trial close-out and retrieval of trial materials
Ensure essential documents are complete and compliant with ICH GCP and regulations
Conduct on-site file reviews
Provide trial status tracking and progress reports
Maintain complete and accurate study systems, including CTMS
Facilitate communication among investigative sites, the client company, and internal project teams
Respond to company, client, and regulatory requirements, audits, and inspections
Complete expense reports and timesheets
Assist with project publications and tools, contribute ideas, and support process improvement initiatives

Requirements

What you’ll need

Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
Minimal clinical monitoring experience comparable to 2 years in a clinical environment involving clinical trials, medical terminology, medical research, clinical research, or health care; or experience in a health sciences field with formal training in medical terminology and anatomy
Equivalency of appropriate education, training, and/or directly related experience may be considered
Valid driver's license where applicable
Basic medical/therapeutic area knowledge and medical terminology
Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations, and procedural documents
Good oral and written communication skills, including communication with medical personnel
Good interpersonal skills
Customer focus, listening skills, attention to detail, and ability to perceive underlying customer issues
Good organizational and time management skills
Flexibility and adaptability
Well-developed critical thinking, root cause analysis, and problem-solving skills
Ability to manage Risk Based Monitoring concepts and processes
Ability to work independently or in a team
Solid knowledge of Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Travel requirement greater than 75%

Benefits

Comp & perks

Hybrid work arrangement
Full-time employment
Standard Monday-Friday work schedule