Regulatory Operations Specialist

🕒 il y a 10 jours

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The START Center for Cancer Research

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501 - 1000 employés

🏥 Santé

💊 Pharmaceutique

🧬 Biotechnologie

Healthcare • Pharmaceuticals • Biotechnology

Le START Center for Cancer Research est une organisation mondiale de recherche clinique axée sur les essais en oncologie de phase précoce et l'avancement des thérapies contre le cancer. START exploite de grands centres de recherche de classe mondiale aux États-Unis et en Europe et dirige des programmes (tel que le START Hope Hub) pour aider les patients et les familles à trouver, comprendre et s'inscrire aux essais cliniques. START sert les patients, les médecins référents, les hôpitaux et les pratiques oncologiques, ainsi que les partenaires pharmaceutiques, en mettant l'accent sur un large accès aux essais cliniques et à la recherche translationnelle sur le cancer.

Description

• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB as assigned under supervision. • Serve as primary point of contact with the Sponsor/CRO in negotiating the IC for IRB submission. • Serve as the main point of contact with the IRB for the studies. • Enter work activity in Regulatory Operations tracking system(s) and generate status reports as required. • Respond to inquiries and follow up on pending items. • Prepare and submit study documents to the IRB for assigned studies under supervision. • Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned under supervision. • Serve as the main point of contact with the IBC for the studies. • Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned under supervision. • Maintain ISF (paper and/or electronic) for assigned studies.

🎯 Exigences

• High School Diploma/GED • 5 years of experience in a regulatory research setting • Proficient working knowledge of Microsoft Outlook 365 • Prior experience with regulatory document management system (i.e. Veeva, Advarra E-Reg) • Strong organizational skills and a sense of timeliness in completing projects • Strong knowledge of medical and clinical research terminology.

🏖️ Avantages

• Comprehensive health coverage: Medical, dental, and vision insurance provided • Robust retirement planning: 401(k) plan available with employer matching • Financial security: Life and disability insurance for added protection • Flexible financial options: Health savings and flexible spending accounts offered • Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided