Principal Clinical Research Associate - Full-Time or Part-Time Available

Thermo Fisher Scientific

Principal Clinical Research Associate leading clinical monitoring and site management for complex clinical trials. Working at Thermo Fisher Scientific, focusing on high-risk studies and subject safety.

Posted 7/24/2026full-timeRemote • 🇩🇪 GermanyJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical trial monitoring activities, ensuring compliance with ICH-GCP and German/EU regulations, while applying advanced problem-solving methodologies. Proficient in conducting site visits, mentoring CRAs, and optimizing processes for improved trial outcomes.

Highest-signal resume keywords

Clinical Trial MonitoringICH-GCP ComplianceRoot Cause AnalysisData Accuracy and IntegrityFluency in German and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research AssociateRisk-Based MonitoringSDR ReviewSDV ReviewCRF ReviewSite InitiationSite MaintenanceSite Close-OutCorrective and Preventive ActionsMonitoring Report Authoring

Soft Skills

Critical ThinkingProblem-SolvingMentoringCommunicationCollaboration

Tools & Technologies

CTMS

Industry Keywords

Clinical TrialsInvestigational Product AccountabilityInspection-Ready DocumentationProcess OptimizationTrial Financial Oversight

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead monitoring activities for complex, high-risk, or strategically important clinical trials using a risk-based monitoring approach
Independently conduct on-site and remote monitoring visits in line with approved monitoring plans
Perform and oversee SDR, SDV, and CRF review, ensuring the highest standards of data accuracy and integrity
Evaluate investigational product accountability through physical inventory and records review
Ensure essential documents are complete, inspection-ready, and compliant with ICH-GCP and applicable German/EU regulations
Lead site initiation, maintenance, and close-out activities, providing expert guidance and recommendations
Apply advanced root cause analysis (RCA), critical thinking, and problem-solving methodologies to identify systemic site issues
Serve as a trusted partner to investigative sites, sponsors, and internal project teams
Identify trends across sites and studies and provide strategic recommendations to the Clinical Team Manager (CTM)
Ensure accurate and timely updates of study systems (e.g. CTMS) and perform QC reviews where required
Participate in investigator meetings and support investigator identification and feasibility activities
Support investigator payment processes and trial financial oversight as applicable
Actively mentor, coach, and support the development of junior and senior CRAs
Contribute to project-specific and functional training initiatives
Identify opportunities for process optimization and drive implementation of improvements
Maintain timely and accurate completion of timesheets, expense reports, and required documentation
Maintain frequent communication with sites between visits to ensure ongoing compliance and issue resolution
Drive corrective and preventive actions (CAPAs) to resolution and proactively mitigate risk
Author high-quality monitoring reports and follow-up correspondence in a timely manner
Act as a key escalation point for significant site issues, protocol deviations, and compliance risks

Requirements

What you’ll need

Bachelor’s degree in a life sciences related field or equivalent qualification
Minimum 5 + years of experience as a Clinical Research Associate / Monitor
Valid driver’s license
Full right to work in Germany
Fluency in German and English (C1 level)

Benefits

Comp & perks

Flexible working models that support work-life balance
Permanent employment