Clinical Research Associate II – Senior Clinical Research

🔥 18 minutes ago

🗣️🇩🇪 German Required

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Logo of CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services

1001 - 5000 employees

Founded 1999

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

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 main CTI contact for assigned study sites • Conduct site visits and complete site visit deliverables with quality and within given timelines • Assist with or oversee study start-up activities, including feasibility and site selection • Collect, review and track essential/regulatory documents • Participate in investigator, client and project team meetings • Create and implement subject enrollment strategies for assigned study sites • Ensure proper storage, dispensation and accountability of Investigational Product (IP) • Perform site management activities and provide ongoing updates of site status to Clinical Project Manager • Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan • Utilize systems and reports to track subject status

🎯 Requirements

• 3 - 5 years clinical research experience as a CRA or related profession in Germany • Independent monitoring experience in Germany • Life science background • Excellent knowledge in ICH-GCP and regulatory requirement • Fluent (at least Level B2) in spoken and written language German and English

🏖️ Benefits

• Flexible working opportunities • Structured mentoring program • Leadership development courses • Ongoing education support

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