Thermo Fisher Scientific Is Hiring A Senior Cra I

Explore an exciting opportunity to join a global leader in clinical research, supporting top pharmaceutical and biotech companies with a focus on innovative healthcare solutions. This role offers the chance to make a significant impact in the field of clinical trials, working with diverse teams across the globe.

Work Schedule & Environment

• Schedule: Standard (Monday to Friday) 🗓️
• Conditions: Office-based 🏢

Join Us as a Senior Clinical Research Associate I - German & French Speaking

Make an impact at the forefront of innovation! We have successfully supported over 50 top pharmaceutical companies and more than 750 biotech firms, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you'll have the opportunity to:

• Perform and coordinate all aspects of clinical monitoring and site management
• Conduct remote or on-site visits to ensure protocol and regulatory compliance
• Manage documentation and monitor procedures across various sponsor environments (FSO, FSP, government, etc.)
• Guarantee subjects' rights, safety, and data integrity by adhering to ICH-GCP guidelines and SOPs
• Develop collaborative relationships with investigational sites and ensure audit readiness

What You'll Do

• Risk-Based Monitoring: Monitor investigator sites, apply root cause analysis (RCA), and implement corrective actions to ensure compliance and minimize risk 🚦
• Data Verification: Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote activities 📊
• Inventory & Documentation: Assess investigational products via physical inventory and records review; document findings clearly and timely 🗃️
• Issue Escalation & Resolution: Report deficiencies to clinical management and follow through to resolution 🔄
• Continuous Site Monitoring: Maintain communication with investigative sites to ensure protocol adherence and resolve issues between visits 📞
• Monitoring & Reporting: Conduct tasks according to approved plans, participate in investigator payments, and update study systems like CTMS 📝
• Investigator Engagement: Identify and initiate trial sites, ensure documentation completeness, and manage trial close-out procedures 🏁
• Compliance & Documentation: Verify essential documents meet ICH-GCP and regulatory standards, and conduct on-site file reviews 📂
• Team Collaboration & Communication: Assist in project publications, share ideas, and facilitate effective communication with all stakeholders 💬
• Regulatory & Administrative Tasks: Respond to audits, maintain expense reports, and contribute to process improvements ⚙️

Education & Experience Requirements

• Bachelor's degree in life sciences, nursing certification, or equivalent + relevant experience
• Minimum of 2+ years of clinical research monitoring experience 🔬
• Valid driver’s license (where applicable) 🚗
• Equivalent combinations of education and experience may be considered

Knowledge, Skills & Abilities

• Strong clinical monitoring skills and understanding of medical/therapeutic areas (preferably oncology) 🎓
• Solid grasp of ICH-GCP guidelines, regulations, and procedures 📚
• Critical thinking, investigation, and problem-solving expertise 🔍
• In-depth understanding of Risk-Based Monitoring concepts
• Excellent communication skills, both oral and written, capable of liaising effectively with medical personnel 🗣️✍️
• Customer-focused approach with a proactive mindset