Remote Clinical Regulatory Specialist

OneOncology, LLC; United States; Remote; USD 70,000 - 95,000; Full time

Benefits offered by this job

Remote position (CT hours)

Job summary

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to support regulatory aspects across our network. You will ensure regulatory compliance for clinical trials, assist with IRB/IBC submissions, and coordinate regulatory activities with cross-functional teams to drive compliant study start-up and ongoing performance.

The role emphasizes proactive risk assessment, timely communications, and collaboration with investigators and site teams to maintain high standards of regulatory

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing or related field.
• 1–2 years of clinical research experience with regulatory affairs.
• Experience with IRB submissions is required.

Responsibilities

• Stay current with evolving regulatory requirements (FDA, ICH-GCP) and communicate updates to teams.
• Manage a high-volume portfolio of regulatory activities with tight deadlines.
• Track timelines, milestones, risks, and provide clear status updates to stakeholders.
• Prepare and maintain regulatory documents and submissions (IRB/IBC).
• Coordinate regulatory submissions to authorities and sponsor systems for timely study start-up.
• Review study documents to ensure regulatory feasibility and compliance.
• Draft and negotiate ICFs and site-specific language per FDA requirements.
• Audit and maintain central electronic regulatory binder for compliance.
• Serve as SME on compliance, training, and cross-functional collaboration.

Skills

Regulatory affairs

Clinical trial processes

Regulatory submissions

IRB submissions

FDA guidelines

ICH-GCP

Communication

Organizational skills

Education

Bachelor's degree in life sciences/healthcare

Advanced degree preferred

Tools

CTMS

EDC systems

Electronic regulatory binder system

Microsoft Office

Job description

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to support regulatory aspects across our network. You will ensure regulatory compliance for clinical trials, assist with IRB/IBC submissions, and coordinate regulatory activities with cross-functional teams to drive compliant study start-up and ongoing performance.

The role emphasizes proactive risk assessment, timely communications, and collaboration with investigators and site teams to maintain high standards of regulatory