Regulatory Operations Assistant

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $22 - $24 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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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

• Maintain the Investigator Site File (ISF), paper and/or electronic, for assigned investigational drug studies • Manage Institutional Review Board (IRB) submissions, approvals, study documents, and correspondence • Create, update, review, and finalize Delegation of Authority Logs and related systems • Obtain Investigator signatures on protocols, amendments, Investigator’s Brochures, logs, and other study-specific documents • Retrieve, review, process, submit, and file IND Safety, SUSAR, and other interim safety reports • Handle monitor visits, including ISF access, Monitor Visit Logs, monitor assistance, and monitor-change notifications • Receive, route for signature, and file incoming monitor letters • File protocol-specific, EDC, and CITI training documentation • Maintain and track Investigator CVs and licenses • Prepare ISFs for archiving and perform final Quality Assurance checks • Manage CITI training completion, renewal reminders, and follow-up • Intake and process revised study documents for IRB submission, including stamping, filing, notifications, database logging, OnCore task lists, and spreadsheets • Complete and obtain signatures on updated Form FDA 1572s and Financial Disclosure Forms • Maintain laboratory certifications, normal ranges, Lab Director CVs, and licenses

🎯 Requirements

• High school diploma or equivalent • Proficient working knowledge of Microsoft Word • Strong organizational skills and a sense of timeliness in completing projects • Detail-oriented with good spelling, composition and proofreading skills • Ability to complete tasks with minimal supervision, understand instructions, and compose reports and correspondence • Ability to sit for extended periods of time • Ability to type and use a computer for extended periods of time

🏖️ Benefits

• 401(k) retirement savings plan with employer match • Eligibility for an annual performance bonus, based on role and company results • Generous paid time off and paid holidays • Comprehensive medical, dental, and vision coverage and optional insurance options • Company paid life and disability insurance • Employee Assistance Program (EAP) providing confidential, no-cost support for you and your family from day one • Flexible FSA and HSA plans • Supportive environment that values balance, wellbeing, and flexibility • Continuous learning and professional growth opportunities • Collaborative, creative, inclusive workplace