
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.
🔥 13 minutes ago
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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.
• Serve as the main CTI contact for assigned study sites • Conduct pre-study, site initiation, interim monitoring, and close-out site visits • Complete site visit deliverables according to the Monitoring Plan and required 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 training and investigator, client, and project team meetings • Create and implement subject enrollment strategies for assigned sites • Ensure proper storage, dispensation, and accountability of investigational product and trial-related 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 • Use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product • Assist with project-specific activities as a Project Team member
• 3–5 years of clinical research experience as a CRA or related profession • Life science background • Excellent knowledge of ICH-GCP and regulatory requirements • Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits • Ability to complete site visit deliverables within required timelines • Knowledge of applicable regulatory requirements, SOPs, and ICH GCP • Ability to assist with or oversee study start-up activities, feasibility, pre-study activities, and site selection • Ability to collect, review, and track essential/regulatory documents • Ability to complete required general and study-specific training • Ability to participate in investigator, client, and project team meetings, including presentations • Ability to create and implement subject enrollment strategies • Ability to manage investigational product and trial-related materials • Ability to perform site management and remote monitoring activities • Ability to use systems and reports to track subject status, CRF retrieval/source document review, regulatory documents, and investigational product
• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and global giving opportunities • Work supporting the development of life-changing treatments
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