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 guidelines and regulatory standards. Proficient in risk-based monitoring, data accuracy verification, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Monitoring SkillsICH GCP ComplianceRisk-Based MonitoringRoot Cause AnalysisEffective Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSource Data VerificationProtocol ComplianceData Accuracy ReviewInvestigational Product AssessmentDocumentation ManagementMonitoring Plan ExecutionRegulatory ComplianceProblem-SolvingCritical Thinking

Soft Skills

Interpersonal SkillsOrganizational SkillsTime ManagementCustomer FocusFlexibility

Tools & Technologies

Microsoft OfficeClinical Trial Management Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical ResearchMedical TerminologySOPsAudit-Ready DocumentationInvestigative Site 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 documentation and procedures across different sponsors and monitoring environments
Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
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 data review, source data verification, and CRF review
Assess investigational product inventory and records
Document observations in reports and letters and escalate deficiencies through resolution
Maintain contact with investigative sites between monitoring visits
Conduct monitoring tasks according to approved monitoring plans
Participate in investigator payments and investigator meetings
Track trial status and provide progress updates to the Clinical Team Manager
Update and quality-check clinical trial management systems
Identify potential investigators and initiate clinical trial sites
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete and audit-ready
Conduct on-site file reviews
Support project publications, tools, process improvements, and other project initiatives
Facilitate communication between sites, the client company, and the project team
Respond to company, client, and regulatory requirements, audits, and inspections
Complete expense reports, timesheets, and other administrative tasks

Requirements

What you’ll need

Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
2+ years of experience 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 areas 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
Ability to communicate with medical personnel
Customer focus, listening skills, attention to detail, and ability to identify underlying issues
Interpersonal, 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 work upright or stationary for 6–8 hours per day
Ability to lift/carry up to 15–20 lbs
Ability to perform under stress, multitask, and maintain regular attendance

Benefits

Comp & perks

Frequent travel generally 60–80% or more, with extended overnight stays possible
Work in office, laboratory, clinical, and/or home office environments
Personal protective equipment provided/required, including protective eyewear, garments, and gloves
Exposure to sponsor/client/site-specific requirements and support for required disclosures