Clinical Research Associate II – Senior Clinical Research, CRA

🔥 4 minutes ago

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

🎯 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

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education and professional growth support • Hybrid work opportunities • CTI Cares opportunities to give back to the community and world • Award-winning people-focused culture • Work contributing to advancing medicine and developing life-changing treatments