Senior Clinical Research Associate

Thermo Fisher Scientific

. Perform and coordinate clinical monitoring and site management activities .

Posted 11/3/2026full-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 regulatory standards while effectively communicating with investigative sites and managing trial documentation. Proficient in risk-based monitoring and problem-solving to enhance trial efficiency and data accuracy.

Highest-signal resume keywords

Clinical Research MonitoringICH-GCP ComplianceRisk-Based MonitoringEffective Communication SkillsRoot Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringData VerificationSource Document ReviewRegulatory ComplianceTrial Management SystemsMedical TerminologyProcess ImprovementDocumentation ManagementInventory AssessmentQuality Control Checks

Soft Skills

Attention to DetailOrganizational SkillsTime ManagementInterpersonal SkillsFlexibility

Tools & Technologies

Microsoft OfficeClinical Trial Management Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsInvestigational ProductsAudit ReadinessSite ManagementProtocol Compliance

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 source document review, source data verification, and CRF review
Assess investigational product inventory and records
Prepare timely reports and letters documenting 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
Track trial status and provide progress reports to the Clinical Team Manager
Update clinical trial management systems and perform required quality-control checks
Identify potential investigators and initiate clinical trial sites
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete and compliant with ICH-GCP and regulations
Conduct on-site file reviews
Contribute to project publications, tools, process improvements, and other initiatives
Facilitate communication among investigative sites, the client company, and the project team
Respond to company, client, regulatory requirements, audits, and inspections
Complete expense reports, timesheets, and other administrative tasks
Travel frequently to site locations, generally 60–80% or more, with possible overnight stays

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 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 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% or more
Ability to work in office, laboratory, clinical, and/or home office environments
Ability to handle potential exposure to biological fluids and use required personal protective equipment
Ability to perform the listed physical requirements, including standing, mobility, bending, lifting 15–20 lbs, and frequent travel

Benefits

Comp & perks

Full-time employment
Hybrid work arrangement
Standard Monday–Friday work schedule
Home office environment option
Travel and overnight stays associated with the role