Clinical Research Associate I/II

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 10/5/2026full-timeRemote • PolandJuniorMid-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 applicable regulations. Proficient in conducting risk-based monitoring, root cause analysis, and maintaining accurate clinical trial documentation.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH-GCP ComplianceOncology MonitoringRoot Cause AnalysisClinical Trial Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical TrialsMedical TerminologyRisk Based MonitoringData Accuracy VerificationProtocol ComplianceDocument ManagementSite AssessmentCritical ThinkingProblem SolvingAnatomy Knowledge

Soft Skills

Good Communication SkillsInterpersonal SkillsCustomer FocusAttention to DetailOrganizational Skills

Tools & Technologies

Microsoft OfficeClinical Trial Management Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchHealth SciencesMedical ResearchOncologyRegulatory Compliance

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 documentation, sponsor procedures and monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
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 SDR, SDV and CRF review during on-site and remote monitoring
Assess investigational product inventory and records
Document observations in reports and letters using approved business writing standards
Escalate deficiencies and issues to clinical management and follow them through resolution
Maintain contact with investigative sites between monitoring visits
Conduct monitoring tasks according to approved monitoring plans
Participate in investigator payment processes and investigator meetings
Identify potential investigators with client companies
Initiate clinical trial sites and ensure protocol, regulatory and ICH-GCP compliance
Perform trial closeout and retrieve trial materials
Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
Conduct on-site file reviews
Track trial status and provide progress updates
Maintain accurate and current study systems, including Clinical Trial Management Systems
Facilitate communication among investigative sites, client companies and internal project teams
Respond to company, client and regulatory requirements, audits and inspections
Complete expense reports, timesheets and other administrative tasks
Assist with project publications and tools
Share ideas and contribute to project work and process-improvement initiatives

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
Minimal clinical monitoring experience comparable to 2 years in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy
Monitoring experience with Oncology
Valid driver's license where applicable
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain working knowledge of ICH GCPs, applicable regulations and procedural documents
Good oral and written communication skills, including effective 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 and Polish language and grammar skills
Frequent driving to site locations and frequent travel, generally 60-80%, potentially including extended overnight stays
Ability to work with exposure to biological fluids, infectious organisms, electrical office equipment and fluctuating/extreme temperatures on rare occasions
Ability to use required personal protective equipment, including protective eyewear, garments and gloves

Benefits

Comp & perks

Fully remote work arrangement
Full-time employment
Standard Monday-Friday work schedule