Regulatory Operations Specialist

🕒 August 25

🇺🇸 United States – Remote

💵 $25 - $28 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 informed consent documents, to the IRB under supervision • Serve as the primary point of contact with Sponsors/CROs for negotiating informed consent documents for IRB submission • Serve as the main point of contact with IRBs, IBCs, and the FDA for assigned studies • Prepare and submit revised protocols, investigator brochures, informed consents, continuing review reports, closure reports, safety reports, protocol deviations, waivers, and other study documents • Prepare and submit study documents to the Institutional Biosafety Committee • Prepare and submit Expanded Access Studies to the FDA • Enter work activity into Regulatory Operations tracking systems • Generate status reports and respond to inquiries • Follow up on pending items and information • Maintain paper and/or electronic Investigator Site Files for assigned studies, including submissions, approvals, and correspondence

🎯 Requirements

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

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) plan with employer matching • Life and disability insurance • Health savings and flexible spending accounts • Paid time off • Flexible schedule • Remote work choices • Collaborative, creative work environment • Opportunities to learn and grow with the company