CTI Clinical Trial and Consulting Services
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.
Senior Regulatory Affairs Study Start-Up Specialist
🕒 July 22
📊 Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
CTI Clinical Trial and Consulting Services
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.
📋 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
Apply NowSimilar Jobs
🕒 July 22
Compliance Lead overseeing adherence to banking regulations and managing compliance programs at N3XT, a financial services startup bridging traditional markets and blockchain.
🕒 July 22
Senior Advisor conducting branch examinations for compliance at Raymond James. Ensuring adherence to policies, procedures, and regulations in licensed financial environments.
🕒 July 22
Senior Advisor conducting compliance branch examinations at Raymond James. Ensuring adherence with firm policies and regulatory requirements through detailed inspections and documentation.
🕒 July 21
Senior Regulatory Compliance and Revenue Cycle Analyst ensuring compliance with healthcare regulations. This role involves managing billing practices, regulatory alignment, and collaboration with diverse teams.
🕒 July 21
Compliance Specialist handling Neumo's compliance program including submerchant onboarding and due diligence. Conducting KYB reviews and assisting with regulatory and sponsor bank requests.
