Regulatory Operations Specialist (Remote)

About The START Center for Cancer Research

The START Center for Cancer Research is the world's largest network dedicated to early phase oncology clinical trials, having contributed to FDA/EMA approval of over 45 therapies. Rooted in global community oncology centers, START specializes in preclinical and early-phase clinical trials of innovative anti-cancer agents and operates eight clinical trial sites with the largest roster of Principal Investigators worldwide.

Role Overview

We are looking for a Regulatory Operations Specialist I to work remotely. This role involves preparing and submitting regulatory documentation for new and ongoing studies to Institutional Review Boards (IRB), the FDA, and Institutional Biosafety Committees (IBC) across START USA sites. The position includes maintaining Investigator Site Files and supporting study close-out activities.

Key Responsibilities

• Prepare and submit documentation for new studies to the IRB, including drafting informed consents and serving as the primary liaison for Sponsor/CRO negotiations and IRB communications.
• Manage submissions of amended study documents to the IRB such as protocol revisions, investigator brochures, continuing reviews, closure reports, adverse event reports, and protocol deviations.
• Coordinate submissions to the Institutional Biosafety Committee, maintaining communication and tracking status reports.
• Submit Expanded Access Studies to the FDA and communicate with FDA and IRB contacts to ensure compliance and progress.
• Maintain paper and electronic Investigator Site Files ensuring thorough organization of approvals, submissions, and correspondence.
• Organize and oversee Close-Out Visits for assigned studies.
• Participate in weekly Phase I and Site Initiation meetings, addressing regulatory concerns raised and updating tracking systems accordingly.
• Assist in onboarding new Regulatory Operations team members and support Regulatory Operations Assistants as needed.
• Complete assigned tasks to contribute to departmental and organizational performance goals.

Qualifications and Experience

• Bachelor’s degree or equivalent practical experience.
• 0 to 1 year experience in regulatory affairs within clinical research settings.
• Proficiency with Microsoft Outlook 365.
• Experience with regulatory document management systems such as Veeva or Advarra E-Reg.
• Strong organizational abilities and adherence to deadlines.
• Attention to detail including spelling, grammar, and proofreading skills.
• Familiarity with medical terminology.
• Ability to perform tasks independently under supervision and communicate effectively through reports and correspondence.

Physical and Travel Requirements

• Extended periods of sitting.
• Prolonged computer use and typing.

Compensation and Benefits

The annual salary range for this position is $55,000 to $65,000, depending on factors such as location and experience.

• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement plan with employer matching contributions.
• Life and disability insurance for financial protection.
• Health savings accounts and flexible spending accounts available.
• Work-life balance support including paid time off, flexible scheduling, and remote work options.
• Collaborative and creative workplace culture with opportunities for professional growth and involvement in organizational decisions.

Diversity and Inclusion

The START Center is an equal opportunity employer welcoming diversity in the workplace and does not discriminate on any legally protected basis.