Remote Oncology Regulatory Specialist

OneOncology; Nashville (TN); Remote; USD 70,000 - 95,000; Full time

Job summary

OneOncology in Nashville is seeking a Clinical Research Regulatory Specialist to support regulatory affairs across the network. You will ensure FDA alignment, ICH-GCP compliance, and efficient study start-up through completion, coordinating with IRBs, IBCs, sponsors, and site teams.

The role requires 1–2 years in clinical research with regulatory experience, strong attention to detail, and excellent communication.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or related field required.
• Minimum 1–2 years of clinical research experience with regulatory focus.
• At least 1 year of experience with IRB submissions.

Responsibilities

• Maintain up-to-date knowledge of regulatory requirements (FDA, ICH-GCP) and share with network teams.
• Manage high-volume regulatory activities with competing priorities and deadlines.
• Prepare, submit, and maintain IRB/IBC applications, amendments, renewals, and reportable events.
• Coordinate regulatory submissions to authorities, sponsor systems, and ethics committees for timely start-up and compliance.
• Review protocols, IBs, patient materials, and study documents for regulatory feasibility and compliance.
• Draft and negotiate study- and site-specific ICFs to ensure readability and regulatory alignment.
• Establish and audit a central electronic regulatory binder system for accuracy and compliance.
• Serve as regulatory SME for investigators and site teams; train and support on compliance.
• Cultivate relationships across network practices to streamline regulatory workflows.

Skills

Regulatory compliance

ICH-GCP knowledge

FDA guidelines

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Certification in clinical research (SoCRA/ACRP)

Job description

OneOncology in Nashville is seeking a Clinical Research Regulatory Specialist to support regulatory affairs across the network. You will ensure FDA alignment, ICH-GCP compliance, and efficient study start-up through completion, coordinating with IRBs, IBCs, sponsors, and site teams.

The role requires 1–2 years in clinical research with regulatory experience, strong attention to detail, and excellent communication.