Clinical Research Associate I, Klinischer Monitor

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🔥 13 minutes ago

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • Monitors investigator sites with a risk-based monitoring approach. • Assesses investigational product through physical inventory and records review. • Ensures a shared responsibility with other project team members on issues/findings resolution.

🎯 Requirements

• Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification. • Previous experience in a clinical environment with exposure to clinical research, healthcare or clinical trials. • Valid driver's license • Full Right to work in Germany • Fluency in English and German language to at least C1 level.

🏖️ Benefits

• Competitive salary • Opportunity for professional development • Flexible work arrangements