Clinical Research Associate

đŸ”„ 12 minutes ago

đŸ‡«đŸ‡· France – Remote

⏰ Full Time

🟡 Mid-level

đŸ§Ș Clinical Research

đŸ‘» Ghost score 10%

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Logo of CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services

1001 - 5000 employees

Founded 1999

đŸ’Œ Consulting

đŸ„ 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 with quality and within Monitoring Plan timelines ‱ Assist with or oversee study start-up, feasibility, pre-study activities, and site selection ‱ Collect, review, and track essential and regulatory documents ‱ Participate in required general and study-specific training ‱ Participate in investigator, client, and project team meetings, including presentations when needed ‱ Create and implement subject enrollment strategies ‱ Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials ‱ Provide ongoing site-status updates to the Clinical Project Manager ‱ Conduct remote monitoring in accordance with 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 member of the Project Team

🎯 Requirements

‱ 3–5 years of clinical research experience as a CRA or related profession ‱ Independent monitoring experience in Germany ‱ Life science background ‱ Excellent knowledge of ICH-GCP and regulatory requirements ‱ Fluent spoken and written English at least Level B2 ‱ Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits ‱ Ability to perform site management and remote monitoring activities ‱ Ability to manage investigational product and trial-related materials ‱ Ability to collect, review, and track essential and regulatory documents

đŸ–ïž Benefits

‱ Structured mentoring program ‱ Leadership development courses ‱ Dedicated training department ‱ Ongoing education support ‱ Hybrid work opportunities ‱ CTI Cares community and charitable involvement opportunities ‱ Work contributing to life-changing treatments for patients with chronic and critical illnesses

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