Senior Clinical Research Associate II – Germany

🕒 September 30

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out visits • Complete site visit deliverables within monitoring-plan timelines and applicable regulatory, SOP, and ICH-GCP requirements • Assist with or oversee study start-up, feasibility, pre-study activities, and site selection • Collect, review, and track essential and regulatory documents • Participate in investigator, client, and project team meetings, including presentations when required • Create and implement subject-enrollment strategies • Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials • Perform site management activities and provide status updates to the Clinical Project Manager • Conduct remote monitoring according to the study-specific Monitoring Plan • Use systems and reports to track subject status, CRF retrieval, source document verification, regulatory documents, and investigational product • Assist with project-specific activities as a member of the Project Team

🎯 Requirements

• 3–5 years of clinical research experience as a CRA or related profession in Germany • Independent monitoring experience in Germany • Life science background • Excellent knowledge of ICH-GCP and regulatory requirements • Fluent spoken and written German and English, at least Level B2 • Participation in all required general and study-specific training

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and charitable involvement opportunities • Work-life balance support • Opportunity to contribute to developing life-changing treatments

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