Senior Clinical Research Associate

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 10/27/2026full-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 and applicable regulations while effectively communicating with investigative sites and managing trial documentation.

Highest-signal resume keywords

Clinical Research MonitoringICH-GCP ComplianceRisk-Based MonitoringRoot Cause AnalysisEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProtocol ComplianceData Accuracy ReviewInvestigational Product AssessmentTrial Closeout ProceduresDocumentation ManagementReport Quality ChecksMedical Terminology UnderstandingProblem-Solving SkillsMicrosoft Office Proficiency

Soft Skills

Attention to DetailOrganizational SkillsTime ManagementFlexibilityInterpersonal Skills

Tools & Technologies

CTMSStudy Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsRegulatory ComplianceAudit ReadinessInvestigative SitesClinical Team Management

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 and ensure audit readiness
Monitor investigator sites using a risk-based monitoring approach
Apply root cause analysis and problem-solving to identify process failures and corrective/preventive actions
Ensure data accuracy through SDR, SDV, and CRF review
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 payments and investigator meetings
Track trial status and provide progress reports to the Clinical Team Manager
Update study systems, including CTMS, and perform required 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
Contribute to project publications, tools, process improvements, and other assigned study tasks
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

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
Valid driver's license where applicable
Effective clinical monitoring skills
Understanding of medical/therapeutic area knowledge and medical terminology
Understanding and 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 skills and strong attention to detail
Organizational and time management skills
Flexibility and adaptability
Ability to work independently and in a team
Microsoft Office proficiency and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to comply with sponsor/client/site requirements
Ability to travel frequently, generally 60–80%, with travel requirement greater than 75%
Ability to perform the stated physical requirements, including standing, mobility, lifting 15–20 lbs, and working under stress
Regular and consistent attendance

Benefits

Comp & perks

Hybrid work arrangement
Full-time employment