[Hiring] Clinical Research Associate I @Thermo Fisher Scientific

Role Description

This position is for experienced Clinical Research Associates with 1+ years of independent monitoring experience. You will manage clinical trial sites across Germany, ensuring studies are conducted in compliance with the protocol, ICH-GCP, applicable regulations, and company SOPs.

You’ll work autonomously, partner closely with investigative sites, and collaborate with project teams to deliver high-quality, inspection-ready clinical trials.

What You’ll Do

• Perform site monitoring activities (on-site and remote) using a risk-based monitoring approach
• Ensure protocol, ICH-GCP, regulatory, and SOP compliance at investigator sites
• Conduct SDR, SDV, CRF review, and investigational product accountability
• Identify, document, escalate, and follow up on issues through resolution, applying root cause analysis and CAPA principles
• Maintain audit and inspection readiness at all assigned sites
• Build strong, collaborative relationships with investigators and site staff
• Document monitoring activities in timely, high-quality reports and follow-up letters
• Maintain ongoing communication with sites between visits to support issue resolution and data quality
• Ensure study systems (e.g., CTMS) are updated according to study conventions
• Provide trial status updates and metrics to the Clinical Team Manager (CTM)
• Support study start-up, investigator identification, site initiation, and study close-out activities as assigned
• Participate in investigator meetings, audits, inspections, and project team meetings as required
• Additional responsibilities may include supporting process improvement initiatives, mentoring activities, or project-specific tasks aligned with experience.

Qualifications

• Bachelor’s degree in a life sciences related field or equivalent qualification
• Minimum 1+ 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) – interviews will be conducted in German

Requirements

• Strong clinical monitoring skills with hands-on RBM experience
• Excellent understanding and application of ICH-GCP and applicable regulations
• Solid therapeutic area knowledge and medical terminology
• Well-developed critical thinking, problem-solving, and root cause analysis skills
• Strong written and verbal communication skills with medical professionals
• High attention to detail and strong organizational skills
• Ability to work independently while contributing effectively to cross-functional teams
• Flexibility and adaptability in a dynamic project environment
• Proficiency in Microsoft Office and ability to learn clinical systems (e.g., CTMS)

Benefits

• Competitive salary
• Extensive benefits package focused on health and well-being
• Flexible working culture that values work-life balance
• Award-winning learning and development programme

Company Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Through our PPD® clinical research services, we support clinical trials in more than 100 countries, delivering laboratory, digital and decentralized solutions that help bring life-changing therapies to patients faster.

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.