
1001 - 5000 employees
Founded 1999
đŒ Consulting
đ„ Healthcare
đ§Ź Biotechnology
Consulting âą Healthcare âą 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 IâIV 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.
đ„ 12 minutes ago
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1001 - 5000 employees
Founded 1999
đŒ Consulting
đ„ Healthcare
đ§Ź Biotechnology
Consulting âą Healthcare âą 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 IâIV 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.
âą Serve as the main CTI contact for assigned study sites âą Conduct pre-study, site initiation, interim monitoring, and close-out visits âą Complete site visit deliverables with quality and within Monitoring Plan timelines âą Assist with or oversee study start-up, feasibility, pre-study activities, and site selection âą Collect, review, and track essential and regulatory documents âą Participate in required general and study-specific training âą Participate in investigator, client, and project team meetings, including presentations when needed âą Create and implement subject enrollment strategies âą Ensure proper storage, dispensation, and accountability of investigational product and trial-related materials âą Provide ongoing site-status updates to the Clinical Project Manager âą Conduct remote monitoring in accordance with the study-specific Monitoring Plan âą Track subject status, CRF retrieval, source document review, regulatory documents, and investigational product using systems and reports âą Assist with project-specific activities as a member of the Project Team
âą 3â5 years of clinical research experience as a CRA or related profession âą Independent monitoring experience in Germany âą Life science background âą Excellent knowledge of ICH-GCP and regulatory requirements âą Fluent spoken and written English at least Level B2 âą Ability to conduct pre-study, site initiation, interim monitoring, and close-out visits âą Ability to perform site management and remote monitoring activities âą Ability to manage investigational product and trial-related materials âą Ability to collect, review, and track essential and regulatory documents
âą Structured mentoring program âą Leadership development courses âą Dedicated training department âą Ongoing education support âą Hybrid work opportunities âą CTI Cares community and charitable involvement opportunities âą Work contributing to life-changing treatments for patients with chronic and critical illnesses
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