Senior Clinical Research Associate - Medical Device

Thermo Fisher Scientific

. Conduct and coordinate clinical monitoring and site management activities .

Posted 10/7/2026full-timeRemote • 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 guidelines and applicable regulations. Proficient in risk-based monitoring, data accuracy verification, and effective communication with investigative sites and clinical teams.

Highest-signal resume keywords

Clinical Research MonitoringICH-GCP GuidelinesRisk-Based MonitoringEffective Communication SkillsCritical Thinking

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 Trial Documentation ManagementSource Data ReviewCase Report Form ReviewRoot Cause AnalysisData VerificationMedical Terminology UnderstandingProject Publication AssistanceClinical Trial Management SystemsRegulatory ComplianceInvestigator Site Management

Soft Skills

Attention to DetailInterpersonal SkillsOrganizational SkillsTime ManagementCustomer Focus

Tools & Technologies

Microsoft OfficeClinical Trial Management Software

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Clinical TrialsProtocol ComplianceAudit ReadinessInvestigational Product ManagementSite Initiation and Closeout

About the role

Key responsibilities & impact

Conduct 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 sponsor procedures
Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
Maintain audit readiness and collaborative relationships with investigational sites
Monitor investigator sites using risk-based monitoring, root cause analysis and corrective/preventive actions
Ensure data accuracy through source data review, source data verification and case report form 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
Track trial status and provide progress updates to the Clinical Team Manager
Update and quality-check clinical trial management systems
Participate in investigator meetings and identify potential investigators
Initiate clinical trial sites and support trial closeout and retrieval of materials
Ensure essential documents are complete and conduct on-site file reviews
Assist with project publications, tools, trip report reviews, newsletters and CRA team calls
Facilitate communication among investigative 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
Contribute to project work and process improvement initiatives

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 of experience as a clinical research monitor
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
Critical thinking, root cause analysis and problem-solving skills
Ability to manage Risk Based Monitoring concepts and processes
Effective oral and written communication skills, including communication with medical personnel
Customer focus, listening skills and attention to detail
Effective interpersonal, organizational and time management skills
Ability to remain flexible and adaptable
Ability to work independently or in a team
Proficiency in Microsoft Office and ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosures
Ability to use required personal protective equipment
Ability to travel frequently, generally 60-80%, including possible extended overnight stays

Benefits

Comp & perks

Frequent travel, generally 60-80% but more for some individuals
Remote work arrangement with remote and on-site monitoring activities
Standard Monday-Friday work schedule