Regulatory Coordinator

Vaga não está no LinkedIn

🕒 Abril 21

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $59.829 - $99.960 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

Candidatar-se

Encontrar Vagas Remotas Similares

Receber Emails de Vagas Remotas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Duke Careers

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1924

📚 Educação

🤝 Sem Fins Lucrativos

🌍 Impacto Social

Education • Non-profit • Social Impact

Duke Careers é uma plataforma conectada ao rico legado da Duke University, fundada em 1924. Seu objetivo é celebrar o centenário da Duke University enquanto oferece recursos, histórias e entrevistas que refletem a história da universidade, suas conquistas atuais e suas aspirações futuras. Um foco essencial do Duke Careers é engajar ex-alunos e a comunidade, destacando o impacto transformador da educação e da liderança na universidade.

Descrição

• Manage regulatory operations for complex oncology studies by preparing, submitting, and maintaining FDA, IRB, and institutional documentation in collaboration with Principal Investigators (PIs), ORAQ, sponsors, and internal stakeholders • Ensure compliance and audit readiness by maintaining complete regulatory binders, supporting monitoring and audit visits, responding to findings, and implementing corrective actions • Coordinate study and site management activities including site initiation, monitoring, close‑out, document storage, and sponsor/CRO communication using OnCore and eREG systems • Apply and interpret regulatory, institutional, and federal requirements to protocols, consent documents, SOPs, and operational plans, including support for international studies • Contribute to team leadership and training by mentoring peers, developing tools or resources, leading multidisciplinary meetings, and supporting process improvement initiatives

🎯 Requisitos

• Associate’s degree • Minimum of two (2) years of research or regulatory experience in a clinical research setting • Completion of the DOCR North Carolina state‑approved Clinical Research Apprenticeship Program may substitute for one year of experience • Prior experience in oncology clinical trials • Experience supporting complex, interventional, or investigator‑initiated studies • Familiarity with FDA regulatory submissions and IRB processes • Experience working with industry sponsors and/or CROs • Proficiency with clinical research management systems (e.g., OnCore, eREG, iRIS) • Strong written and verbal communication skills

🏖️ Benefícios

• comprehensive and competitive medical and dental care programs • generous retirement benefits • family-friendly and cultural programs