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

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

• 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

• Flexible working models that support work-life balance • Permanent employment