Clinical Research Associate II, Senior, PCRA

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/11/2026full-timeRemote • CanadaSeniorWebsite

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 maintaining collaborative relationships with investigational sites.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP KnowledgeRisk-Based MonitoringRegulatory ComplianceClinical Trial Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Documentation ManagementSource Data ReviewRoot Cause AnalysisCorrective ActionsTrial Closeout ProceduresInventory ReviewData VerificationProtocol Compliance AssessmentMonitoring Plan ExecutionMedical Terminology Understanding

Soft Skills

Critical ThinkingProblem-SolvingAttention to DetailEffective CommunicationOrganizational Skills

Tools & Technologies

Clinical Trial Management SystemsMicrosoft Office

Certifications & Qualifications

Bachelor's Degree in Life-Related FieldRegistered Nursing Certification

Industry Keywords

Clinical ResearchInvestigational SitesAudit ReadinessSOPsSponsor-Specific Procedures

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-specific procedures
Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
Maintain audit readiness and collaborative relationships with investigational sites
Monitor investigator sites using risk-based monitoring, root cause analysis, and corrective/preventive actions
Ensure data accuracy through source data review, source data verification, and CRF review
Assess investigational products through inventory and records review
Document observations in reports and letters
Escalate deficiencies and track issues through resolution
Maintain contact with investigational sites between monitoring visits
Conduct monitoring tasks according to approved monitoring plans
Participate in investigator payment processes and investigator meetings
Identify potential investigators and initiate clinical trial sites
Perform trial closeout and retrieve trial materials
Ensure essential documents are complete and properly maintained
Conduct on-site file reviews
Provide trial status tracking and progress updates to the Clinical Team Manager
Update clinical study systems, including Clinical Trial Management Systems
Facilitate communication among investigational sites, clients, and the PPD project team
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-related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
Previous experience comparable to 1 year as a clinical research monitor, or completion of the 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 areas 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
Customer focus, listening skills, attention to detail, and ability to identify underlying issues
Organizational and time-management skills
Effective 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
Ability to travel independently up to 80% by automobile, airplane, and train
Ability to work in non-traditional work environments and use standard office equipment and technology

Benefits

Comp & perks

Health and well-being support
Accessibility service and disability accommodations for the application process
Full-time employment
Fully remote work arrangement
Global team and mission-driven work environment