Senior Clinical Research Associate

Thermo Fisher Scientific

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

Posted 11/2/2026full-timeNorth Carolina • United StatesSeniorWebsite

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 management, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring SkillsICH-GCP ComplianceRisk-Based MonitoringCritical ThinkingMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research MonitoringProtocol ComplianceRoot Cause AnalysisData Accuracy VerificationSite ManagementDocumentation ManagementTrial Closeout ProceduresInvestigator Site AssessmentSDR, SDV, CRF ReviewProject Publication Assistance

Soft Skills

Effective CommunicationInterpersonal SkillsOrganizational SkillsTime ManagementProblem-Solving

Tools & Technologies

CTMSStudy SystemsMonitoring Plan DocumentationExpense Reporting Software

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsInvestigational SitesAudit ReadinessRegulatory ComplianceMedical Terminology

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
Manage required documentation and sponsor/monitoring-environment procedures
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Maintain audit readiness and collaborative relationships with investigational sites
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis, critical thinking and problem-solving to address site process failures
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
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
Track trial status and provide progress reports to the Clinical Team Manager
Update study systems such as CTMS and perform required CTMS report quality checks
Identify potential investigators and initiate clinical trial sites
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete according to ICH-GCP and applicable regulations
Conduct on-site file reviews
Assist with project publications/tools and other study tasks
Facilitate communication between 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 work and process-improvement initiatives

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
2+ years as a clinical research monitor or comparable experience
Valid driver's license where applicable
An equivalency combining appropriate education, training and/or directly related experience may be considered
Effective clinical monitoring skills
Understanding of medical/therapeutic area knowledge and medical terminology
Understanding and demonstrated application 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
Effective oral and written communication skills
Effective interpersonal, organizational and time management skills
Ability to work in a team or independently
Microsoft Office proficiency and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to comply with specific sponsor/client/site requirements
Ability to travel frequently and drive to site locations
Ability to perform required physical activities, including standing, mobility, bending, lifting 15-20 lbs, and working under stress

Benefits

Comp & perks

Frequent travel, generally 60-80% but more for some individuals
Extended overnight stays may be included
Work may be performed in a home office environment
Personal protective equipment provided/required, including protective eyewear, garments and gloves