Senior CRA - FSP - Medical Device

Thermo Fisher Scientific

Senior Clinical Research Associate coordinating all aspects of clinical trials for a global team. Ensuring compliance with protocols and regulatory obligations for investigational sites across North America.

Posted 7/24/2026full-timeRemote • Montana • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in risk-based monitoring, root cause analysis, and compliance with ICH-GCP regulations. Proven ability to develop collaborative relationships with clinical trial sites and ensure audit readiness.

Highest-signal resume keywords

Risk-Based MonitoringRoot Cause AnalysisClinical Trial ComplianceICH-GCP RegulationsClinical Research Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringTrial Status TrackingCorrective ActionsPreventive ActionsSite Process Analysis

Soft Skills

Critical ThinkingProblem-SolvingCollaboration

Certifications & Qualifications

Bachelor's Degree in Life SciencesRegistered Nursing Certification

Industry Keywords

Audit ReadinessEssential DocumentsRegulatory ObligationsInvestigational Sites

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures audit readiness and develops collaborative relationships with investigational sites.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Initiates clinical trial sites according to relevant procedures to ensure compliance with protocol and regulatory obligations.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.

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.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver's license where applicable
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Benefits

Comp & perks

Flexible work arrangements
Professional development opportunities