Remote Clinical Research Regulatory Specialist

OneOncology, LLC; United States; Remote; USD 65,000 - 95,000; Full time

Benefits offered by this job

Remote work with CST hours

Job summary

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to assure regulatory compliance across the OneOncology network. You will collaborate with the OneR operations team and practices to streamline regulatory processes and support clinical research from initiation to completion.

In this role you will manage IRB/IBC submissions, maintain regulatory binders, and act as a SME providing guidance on FDA, ICH-GCP, and sponsor requirements. Remote CST hours support.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing or related field.
• 1–2 years of experience in clinical research with regulatory affairs focus.
• Experience with IRB submissions.
• Familiarity with electronic data capture (EDC) systems and CTMS.

Responsibilities

• Ensure adherence to evolving regulatory requirements (FDA, ICH-GCP) and industry standards; disseminate updates and assess impact.
• Manage high-priority regulatory activities with tight deadlines; track timelines and milestones.
• Prepare, submit, and maintain regulatory documents (IRB/IBC applications; amendments; renewals; reportable events).
• Coordinate regulatory submissions to authorities, sponsors, and ethics committees to ensure timely compliance.
• Review study documents (protocols, IBs, patient materials) for regulatory feasibility and compliance.
• Draft and negotiate study- and site-specific ICFs to meet FDA requirements and sponsor/site needs.
• Maintain central electronic regulatory binder; ensure files are complete and compliant.
• Serve as SME to investigators and site teams; provide guidance and training on compliance.
• Foster strategic relationships across network practices to streamline regulatory workflows.

Skills

Regulatory affairs

Clinical trials

IRB submissions

Documentation

Communication

Education

Bachelor's degree in life sciences/nursing/pharmacy

Tools

CTMS

EDC systems

Microsoft Office

Job description

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to assure regulatory compliance across the OneOncology network. You will collaborate with the OneR operations team and practices to streamline regulatory processes and support clinical research from initiation to completion.

In this role you will manage IRB/IBC submissions, maintain regulatory binders, and act as a SME providing guidance on FDA, ICH-GCP, and sponsor requirements. Remote CST hours support.