Senior Clinical Research Associate

Thermo Fisher Scientific

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

Posted 10/22/2026full-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 regulatory standards while effectively communicating with investigative sites and managing trial documentation. Proficient in risk-based monitoring and applying critical thinking to resolve site process issues.

Highest-signal resume keywords

Clinical MonitoringICH-GCP ComplianceRisk-Based MonitoringCritical ThinkingEffective Communication

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Research MonitoringRoot Cause AnalysisData Accuracy VerificationProtocol Compliance AssessmentDocumentation ManagementTrial Closeout ProceduresCTMS ReportingMedical TerminologyRegulatory CompliancePhysical Inventory Assessment

Soft Skills

Interpersonal SkillsOrganizational SkillsTime ManagementProblem-Solving SkillsPresentation Skills

Tools & Technologies

CTMSMicrosoft OfficeStudy Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsInvestigational ProductsAudit ReadinessSite ManagementRegulatory Requirements

About the role

Key responsibilities & impact

Perform and coordinate all aspects of clinical monitoring and site management
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, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
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 study systems, including CTMS, and perform required CTMS report quality checks
Identify potential investigators and initiate clinical trial sites in accordance with procedures, protocol, regulatory, and ICH-GCP obligations
Ensure trial closeout and retrieval of trial materials
Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
Conduct on-site file reviews
Contribute to 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 relevant experience
Valid driver's license where applicable
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Excellent 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
Good computer skills, including Microsoft Office 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, generally 60–80%, with the posting also stating a travel requirement greater than 75%
Ability to work in office, laboratory, clinical, and/or home office environments
Ability to perform required physical activities, including standing 6–8 hours per day, frequent mobility, bending/twisting, and lifting 15–20 lbs
Ability to perform under stress, multitask, and maintain regular and consistent attendance

Benefits

Comp & perks

No specific benefits or compensation extras stated
Full-time employment
Hybrid work arrangement
Standard Monday–Friday work schedule