CTI Clinical Trial and Consulting Services
1001 - 5000 employees
Founded 1999
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
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.
Senior Regulatory Affairs Study Start-Up Specialist
🔥 3 hours ago
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CTI Clinical Trial and Consulting Services
1001 - 5000 employees
Founded 1999
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
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
• Independently manage essential regulatory documentation for submission to various bodies for clinical studies • Assist project teams on regulatory requirements • Perform compliance assessments and notify Project Managers of findings • Review and adapt study specific documents • Oversee IRB/EC/CA submissions on behalf of sponsors • Interact with site personnel for document corrections • Compile regulatory documentation according to applicable country requirements • Prepare for sponsor or agency audits and inspections
🎯 Requirements
• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience • At least 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
🏖️ Benefits
• Health benefits • Paid parental leave • Tuition reimbursement • Training courses • Work-life balance • Generous vacation packages
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