Regulatory Affairs Study Start Up Specialist

🕒 Setembro 30

🐎 Kentucky, North Carolina – Remoto

🐎 Kentucky – Remote 🌲 North Carolina – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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CTI Clinical Trial and Consulting Services

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1999

💼 Consultoria

🏥 Saúde

🧬 Biotecnologia

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services é uma organização de pesquisa por contrato (CRO) de serviço completo que fornece execução de ensaios clínicos, estratégia regulatória, serviços de laboratório e bioanalíticos, geração de evidências do mundo real e gestão de centros de pesquisa para patrocinadores de biotecnologia e farmacêuticos. Com expertise em estudos de Fase I a IV e áreas terapêuticas complexas (incluindo doenças raras, terapia celular e gênica, oncologia, neurologia e transplante), a CTI apoia o desenho de estudos, gestão de sites, recrutamento de pacientes, monitoramento, segurança/farmacovigilância, biometria e garantia de qualidade. Com sede em Covington, KY, a empresa enfatiza abordagens integradas e centradas no paciente e orientação regulatória global para acelerar o desenvolvimento e levar terapias aos pacientes.

Descrição

• Manage essential regulatory documentation for clinical studies throughout the study lifecycle • Assist and advise project teams on regulatory requirements • Perform compliance assessments and notify Project Managers of findings • Review and adapt study-specific documents for country and site requirements • Perform IRB/EC/CA submissions on behalf of sponsors and/or sites • Receive, process, and quality-check study documentation from sites • Coordinate with site personnel, CPCs, CRAs, PMs, sponsors, and CTI management to resolve documentation issues • Compile regulatory documentation and timelines and perform QC reviews before submission • Assist with and adapt site-specific Informed Consent Forms • Forward regulatory documentation and final submission packages to sponsors as requested • Assist with responses to contingency letters from IRB/IEC/CA • Compile and assess regulatory packages for drug release • Provide periodic regulatory status reports and attend internal and external project meetings • Apply naming conventions and upload/process documentation in study-startup modules, trackers, and TMF systems • Maintain site documentation throughout the trial • Perform review, reconciliation, close-out, and archiving activities • Assist with sponsor or agency audits and inspections • Assist with QC and QA of regulatory documents and reports • Oversee translation of regulatory documents when needed • Attend study meetings and provide regulatory status reports for each site and country

🎯 Requisitos

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science, or equivalent relevant experience • A minimum of 3–5 years of relevant pharmaceutical, site, or CRO Regulatory experience • Ability to manage essential regulatory documentation for global clinical studies • Knowledge of country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA), and other Regulatory Bodies • Ability to perform compliance assessments according to country requirements • Ability to review and adapt study-specific documents to country and site requirements • Ability to perform IRB/EC/CA submissions according to country requirements • Ability to compile, assess, quality check, file, maintain, reconcile, close out, and archive regulatory and study documentation • Ability to assist with Informed Consent Form adaptation according to IRB/IEC requests • Ability to prepare status reports and regulatory submission timelines • Ability to use study start-up modules, trackers, and electronic or paper TMF systems • Ability to assist with sponsor or agency audits and inspections • Ability to oversee translation of regulatory documents when needed

🏖️ Benefícios

• Structured mentoring program • Leadership development courses • Ongoing education and training opportunities • Tuition reimbursement • Generous health benefits • Vacation packages • Hybrid work opportunities • Paid parental leave • CTI Cares community and global giving opportunities