Senior Clinical Research Associate

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/5/2026full-timeNorth Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP and applicable regulations while effectively communicating with investigative sites and managing trial documentation.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP ComplianceRoot Cause AnalysisRisk Based MonitoringEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Documentation ManagementSource Data VerificationCRF ReviewData Accuracy AssessmentInvestigator Site MonitoringTrial Closeout ProceduresClinical Trial Management Systems (CTMS)Medical Terminology UnderstandingProblem-Solving SkillsOrganizational Skills

Soft Skills

Interpersonal SkillsAttention to DetailTime Management SkillsFlexibilityAdaptability

Tools & Technologies

Microsoft OfficeClinical Trial Management Systems (CTMS)

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchRegulatory ComplianceAudit ReadinessInvestigational Product AssessmentSite Management Activities

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 ensure audit readiness
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 source document review, source data verification and CRF review
Assess investigational product through physical inventory and records review
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 the approved monitoring plan
Participate in investigator payment processes and investigator meetings
Track trial status and provide progress updates to the Clinical Team Manager
Update clinical trial systems, including CTMS, and perform report quality-control checks
Identify potential investigators and initiate clinical trial sites in collaboration with the client company
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete and compliant with ICH-GCP and applicable regulations
Conduct on-site file reviews
Support project publications, tools, process improvements and other project initiatives
Facilitate communication among investigative sites, the client company and the PPD project team
Respond to company, client and regulatory requirements, audits and inspections
Complete administrative tasks such as expense reports and timesheets
Perform additional study tasks assigned by the Clinical Team Manager

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
Equivalency through a combination of 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 application of ICH GCPs, applicable regulations and procedural documents
Root cause analysis and problem-solving skills
Ability to manage Risk Based Monitoring concepts and processes
Effective oral and written communication skills
Effective interpersonal skills
Strong attention to detail
Organizational and time management skills
Flexibility and adaptability
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 travel frequently; travel requirement >75%
Ability to work in office, laboratory, clinical and/or home office environments
Ability to comply with specific sponsor/client/site requirements
Ability to perform the stated physical requirements, including frequent mobility, lifting 15–20 lbs, and prolonged upright or stationary work

Benefits

Comp & perks

Full-time employment
Hybrid work arrangement
Standard Monday–Friday work schedule