Regulatory Operations Specialist

About the role

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are hiring for a Regulatory Operations Specialist (Remote) who will prepare and submit documents for new and existing studies to the Institutional Review Board (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC) for review, maintain the Investigator Site File (ISF) for assigned investigational drug studies and corresponding documents at START USA sites. This is a remote role.

Responsibilities

• 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 assigned 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, including revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised ICs, new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, waivers, etc.
• 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 assigned studies.
• Enter work activity in Regulatory Operations tracking system(s), note pending information, and generate status reports as required.
• Respond to inquiries and follow up, as required, on pending IBC items.
• Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned under supervision.
• Serve as the main point of contact with the FDA and IRB for Expanded Access Studies.
• Enter work activity in Regulatory Operations tracking system(s) and generate status reports as required for FDA submissions.
• Respond to inquiries and follow up, as required, on pending FDA items.
• Maintain ISF (paper and/or electronic) for assigned studies, including IRB submissions, IRB 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 regulatory document management system (e.g., Veeva, Advarra E-Reg).
• Strong organizational skills and a sense of timeliness in completing projects.
• Strong knowledge of medical and clinical research terminology.

Qualifications

• Bachelor's degree (preferred).

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.

Pay

The hourly pay for this remote role is $25 – $28/hour. Base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.

Schedule

Remote position with flexible schedule.