Regulatory Operations Assistant

About the Role

The START Center for Cancer Research, a global leader in early-phase oncology clinical trials, is seeking a remote Regulatory Operations Assistant. This role is crucial for maintaining the Investigator Site File (ISF) for various investigational drug studies. The START Center has a significant track record, with over 45 therapies conducted at its sites having received FDA/EMA approval. Join a dedicated team focused on accelerating cancer treatments and bringing hope to patients worldwide.

Responsibilities

• Manage and update the Investigator Site File (ISF), both physical and electronic, for assigned clinical studies. This includes handling Institutional Review Board (IRB) submissions, approvals, study-specific documents, and correspondence.
• Maintain and update Delegation of Authority Logs and other tracking systems to reflect changes in study staff, ensuring accuracy through study close-out.
• Obtain necessary Investigator signatures on key study documents such as Protocols, Amendments, and Investigator’s Brochures, and distribute them to the appropriate Sponsor/CRO contacts.
• Process and submit urgent safety reports, including IND Safety reports and SUSARs, to the IRB and file them appropriately within the ISF.
• Facilitate monitor visits by providing access to the ISF, ensuring log completion, offering assistance, and updating tracking systems with any changes.
• Receive, route for Investigator signature when required, and file incoming correspondence from monitors into the ISF.
• File all training documentation, including protocol-specific, EDC, and GCP training records, ensuring GCP certificates are current.
• Track and maintain Investigator Curriculum Vitae (CVs) and professional licenses.
• Prepare ISFs for archiving by conducting final Quality Assurance checks and verifying the inclusion of all required study file components.
• Process revised study documents for IRB submission, including stamping, filing, notifying the study team, logging into databases, and updating the Clinical Trial Management System (CTMS) as needed.
• Complete and secure Investigator signatures on updated Form FDA 1572s and Financial Disclosure Forms (FDFs).
• Maintain laboratory certifications and normal ranges for core labs, including tracking Lab Director CVs and licenses.
• Collaborate with team members to meet departmental goals and organizational key performance indicators.

Requirements

• High school diploma or equivalent is required.
• Proficiency in Microsoft Outlook 365 is essential.
• Demonstrated strong organizational skills and the ability to complete projects in a timely manner.
• Exceptional attention to detail, including excellent spelling, composition, and proofreading abilities.
• Capacity to work independently with minimal supervision, understand complex instructions, and produce clear reports and correspondence.
• Ability to sit for extended periods and perform computer-based tasks for prolonged durations.

Perks

• Comprehensive health coverage including medical, dental, and vision insurance.
• Retirement savings plan with employer matching (401(k)).
• Life and disability insurance for financial security.
• Health Savings and Flexible Spending Accounts for managing healthcare expenses.
• Generous paid time off and flexible scheduling options.
• Remote work opportunities to support work-life balance.
• A collaborative and creative work environment that encourages employee contribution and professional growth.

Eligibility

This role is open to individuals who meet the specified educational and experience requirements and possess strong organizational and detail-oriented skills. The position is suitable for those seeking a remote, full-time opportunity in regulatory operations within the cancer research field.

Education Required

High school diploma or equivalent.