
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.
🔥 24 minutes ago
🗣️🇮🇹 Italian Required
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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.
• Initiate site contact and follow up as necessary to turn study confidentiality agreements (CDAs) and clinical trial agreements (CTAs) drafts • Administer contract language within approved sponsor guidelines and work with legal counsel on contract revision and negotiation • Facilitate CDA and CTA completion and execution • Attend internal and external project team meetings and report on CDA and CTA progress • Maintain contract files and internal/external CDA and CTA tracking sheets • Update CTA status in the internal study start-up module for assigned studies • Assist with contract preparation, review, revision, execution, and filing • Advise appropriate parties of significant terms, including expiration dates, renewal terms, and compliance obligations • Assist with CDA preparation, review, negotiation, execution, and filing • Maintain CDA tracking and archives • Process new consultant paperwork and maintain files
• Paralegal certification or Associate’s degree • At least two years of experience in a professional administrative/business role • Fluent in spoken and written Italian and English • Application must be submitted in English
• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and charitable engagement program • Work-life balance support
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