FSP CRA II

Thermo Fisher Scientific

. Perform and coordinate all aspects of clinical monitoring and site management .

Posted 11/3/2026full-timeRemote • BrazilJuniorWebsite

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. Proficient in risk-based monitoring, documentation, and effective communication with investigational sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP KnowledgeRisk Based MonitoringProblem-Solving SkillsCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProtocol ComplianceRegulatory ComplianceRoot Cause AnalysisDocumentation ManagementData RecordingTrial ManagementInventory AssessmentSite ManagementMedical Terminology

Soft Skills

Attention to DetailOrganizational SkillsTime ManagementInterpersonal SkillsFlexibility

Tools & Technologies

Microsoft OfficeStudy SystemsDocumentation Tools

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsInvestigational SitesSOPsAudit ReadinessClinical Research

About the role

Key responsibilities & impact

Perform and coordinate all aspects of clinical monitoring and site management
Conduct remote or on-site visits to assess protocol and regulatory compliance and manage documentation
Manage sponsor procedures and guidelines across different monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Ensure audit readiness and develop collaborative relationships with investigational sites
Monitor investigator sites using a risk-based monitoring approach, including RCA, SDR, SDV and CRF review
Assess investigational product through physical inventory and records review
Document observations in reports and letters and escalate deficiencies through resolution
Maintain contact with sites between visits to confirm protocol adherence, issue resolution and timely data recording
Participate in investigator payments, investigator meetings, site identification, site initiation, trial closeout and retrieval of trial materials
Ensure essential documents are complete and conduct on-site file reviews
Provide trial status and progress reports to the Clinical Team Manager and update study systems
Facilitate communication among sites, the client company and the PPD project team
Respond to company, client and regulatory requirements, audits and inspections
Complete expense reports and timesheets
Assist with project publications/tools and contribute to process improvement initiatives
Travel frequently to site locations, generally 60–80%, with possible overnight stays

Requirements

What you’ll need

Bachelor's degree in a life sciences related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Previous experience comparable to 1 year as a clinical research monitor, or completion of PPD Drug Development Fellowship
Valid driver's license where applicable
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Proven clinical monitoring skills
Understanding of medical/therapeutic area knowledge and medical terminology
Working knowledge 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
Good oral and written communication skills, including communication with medical personnel
Customer focus, listening skills, attention to detail and ability to perceive underlying issues
Organizational, time management and interpersonal skills
Flexibility and adaptability
Ability to work independently and in a team
Solid Microsoft Office skills and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule