Regulatory Operations Specialist

🕒 6 days ago

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The START Center for Cancer Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

The START Center for Cancer Research is a global clinical research organization focused on early-phase oncology trials and advancing cancer therapies. START operates large, world-class research facilities across the United States and Europe and runs programs (such as the START Hope Hub) to help patients and families find, understand, and enroll in clinical trials. START serves patients, referring physicians, hospitals and oncology practices, and pharmaceutical partners, emphasizing broad access to clinical trials and translational cancer research.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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