Remote Regulatory Affairs Specialist — Clinical Trials

OneOncology, LLC; Oregon; Hybrid; USD 65,000 - 95,000; Full time

Job summary

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to support regulatory affairs across its network of practices in the United States. The role focuses on ensuring FDA/ICH-GCP compliance, coordinating IRB/IBC submissions, and maintaining regulatory binders.

You will collaborate with cross-functional teams to streamline processes and meet study start-up timelines. The ideal candidate has 1–2 years in clinical research with regulatory experience, proficiency in CTMS and EDC

Qualifications

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• 1–2 years of clinical research experience with regulatory affairs and compliance.
• At least 1 year of IRB submissions experience.
• Proficiency with Microsoft Office; familiarity with EDC, CTMS, and electronic regulatory binders.

Responsibilities

• Maintain knowledge of evolving regulatory requirements (FDA, ICH-GCP) and share updates with network teams.
• Manage high-volume regulatory activities with deadlines and priorities.
• Prepare, submit, and maintain IRB/IBC applications, amendments, renewals, and reportable events.
• Coordinate regulatory submissions to authorities, sponsor systems, and ethics committees.
• Review protocols, IBs, and patient-facing materials for regulatory feasibility and compliance.
• Draft and negotiate ICFs to meet protocol and sponsor/site requirements; address privacy and risk.
• Establish and audit central electronic regulatory binder system for complete regulatory documentation.
• Act as regulatory SME for investigators and site teams and collaborate with QA to resolve issues.
• Cultivate relationships across network practices to streamline regulatory workflows.
• Perform additional responsibilities to support the network's mission.

Skills

Clinical trial processes

Regulatory requirements

ICH-GCP

FDA guidelines

Attention to detail

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Office

EDC systems

CTMS

Electronic regulatory binder

Job description

OneOncology, LLC is seeking a Clinical Research Regulatory Specialist to support regulatory affairs across its network of practices in the United States. The role focuses on ensuring FDA/ICH-GCP compliance, coordinating IRB/IBC submissions, and maintaining regulatory binders.

You will collaborate with cross-functional teams to streamline processes and meet study start-up timelines. The ideal candidate has 1–2 years in clinical research with regulatory experience, proficiency in CTMS and EDC