Clinical Research Associate II

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 10/27/2026full-timeNorth Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring and site management, ensuring compliance with protocols and regulations while applying risk-based monitoring approaches. Proficient in data accuracy verification, root cause analysis, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring SkillsRisk Based MonitoringICH GCP KnowledgeRoot Cause AnalysisClinical Trial Management System

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData VerificationProtocol ComplianceRoot Cause AnalysisRisk Based MonitoringMedical TerminologyInventory ReviewTrial CloseoutSite ManagementRegulatory Compliance

Soft Skills

Critical ThinkingProblem-SolvingCommunication SkillsOrganizational SkillsTime Management

Tools & Technologies

Clinical Trial Management SystemMicrosoft Office

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchInvestigational ProductSite ManagementRegulatory RequirementsClinical 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
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis and corrective/preventive actions to address site process failures
Ensure data accuracy through source document review, source data verification and CRF review
Assess investigational product through inventory and records review
Document observations, escalate deficiencies and follow issues through resolution
Maintain contact with investigative sites between monitoring visits
Conduct monitoring tasks according to the approved monitoring plan
Participate in investigator payment processes and investigator meetings
Identify and initiate qualified clinical trial sites
Perform trial closeout and retrieve trial materials
Ensure essential documents are complete and compliant
Conduct on-site file reviews
Provide trial status tracking and progress updates to the Clinical Team Manager
Update study systems such as the Clinical Trial Management System
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 and timesheets
Contribute to project publications, tools and process-improvement initiatives
Travel requirement greater than 75%

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
Approximately 1 year of experience as a clinical research monitor
Valid driver's license where applicable
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
Organizational and time management skills
Good computer skills, including Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to work in a team or independently
Ability to comply with sponsor/client/site requirements
Ability to work upright and/or stationary for 6–8 hours per day
Ability to lift and carry 15–20 lbs
Regular and consistent attendance