Clinical Research Regulatory Specialist

About OneOncology

OneOncology is building a physician-led, patient-focused, technology-enabled model that helps community oncologists shape the future of care and improve outcomes for people living with cancer and other diseases. The organization is uniting experienced leaders to advance its mission across the market.

The company describes itself as values-driven, with the energy of a startup and the support of leaders from oncology, urology, technology, and finance. It is seeking motivated professionals who enjoy improving processes and contributing to meaningful work that supports independent physicians and their patients.

Role Overview

The Clinical Research Regulatory Specialist will partner with the OneR operations team and OneOncology practices to support clinical research across the network. This role focuses on maintaining regulatory compliance, coordinating trial-related documentation, and helping study activities move smoothly from startup through completion. A key part of the job is working with multiple practices to simplify regulatory workflows and strengthen collaboration.

Responsibilities

• Make sure all clinical research activities follow the required rules and standards, including FDA regulations, ICH guidance, and any local requirements.
• Draft, file, and keep current regulatory paperwork such as IND applications, amendments, and annual reports.
• Manage submissions to regulatory agencies and ethics committees so they are completed accurately and on time.
• Review trial protocols, informed consent forms, and other study documents to confirm they meet regulatory expectations.
• Edit study-specific informed consent forms for clarity, payment and cost language, standard-of-care wording, and all FDA-required elements.
• Prepare, route, and submit essential regulatory materials to sponsors and CROs for network practices.
• Work with investigators and study teams to resolve regulatory questions and provide guidance on compliance requirements.
• Support study start-up activities, including regulatory approvals, binder setup, and site readiness for compliance.
• Keep regulatory files complete, organized, and up to date.
• Create and maintain an electronic regulatory binder system for secure document storage and submission tracking.
• Monitor submission timelines, key milestones, and status updates, then share them with internal stakeholders.
• Train and assist study teams and investigators on procedures, expectations, and best practices related to regulatory work.
• Stay current on changes to regulations and industry standards and share relevant updates with the team.
• Build and sustain strong relationships with practices across the network to improve coordination and regulatory efficiency.
• Take on additional responsibilities as needed to support the organization’s mission.

Key Competencies

• Solid understanding of clinical trial workflows, regulatory expectations, and industry standards such as ICH-GCP and FDA guidance
• High level of accuracy and strong organizational habits
• Clear communication and strong people skills for working with cross-functional teams
• Ability to manage work independently while also contributing effectively in a team setting
• Comfort working in a fast-moving environment

Qualifications

• Bachelor’s degree in a relevant area such as life sciences, pharmacy, or nursing is required
• An advanced degree is preferred
• At least 1 to 2 years of experience in clinical research, especially in regulatory affairs and compliance
• Experience with Microsoft Office and familiarity with EDC systems, electronic regulatory binder tools, and CTMS platforms is preferred
• Clinical research certification such as SoCRA or ACRP is an added advantage

Additional Information

This is a full-time, onsite position based in the United States.

No salary, stipend, start date, or application deadline was specified in the source.