On-Site Regulatory Coordinator: Oncology Trials

Oncology Voice Network LLC; Spring, Northern (TX, KY); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Community Clinical Trials in Spring, TX seeks a Regulatory Coordinator to manage regulatory documents for oncology trials, ensuring compliance with all regulations and sponsor requirements.

The role collaborates with investigators, study teams, sponsors, and CROs to prepare IRB submissions, track timelines, maintain essential documents, and support audits while promoting quality and patient-centered research.

Qualifications

• Experience with regulatory documentation and trial records.
• Ability to interpret clinical research regulations and guidelines.
• Understanding of regulatory requirements for oncology trials.
• Experience managing regulatory submissions to IRBs, sponsors, and authorities.
• Foundational knowledge of regulatory affairs in clinical research or healthcare.

Responsibilities

• Prepare, submit, and maintain regulatory documents for oncology trials.
• Coordinate IRB submissions and renewals and track timelines.
• Maintain regulatory binders and essential documents.
• Support start-up activities and sponsor/CRO regulatory queries.
• Assist with SOP updates and regulatory best practices.

Skills

Regulatory documentation

Regulatory compliance

Regulatory requirements

Regulatory submissions

Regulatory affairs

Attention to detail

Written & verbal communication

Team collaboration

Tools

Office tools

Clinical trial management systems

Job description

Community Clinical Trials in Spring, TX seeks a Regulatory Coordinator to manage regulatory documents for oncology trials, ensuring compliance with all regulations and sponsor requirements.

The role collaborates with investigators, study teams, sponsors, and CROs to prepare IRB submissions, track timelines, maintain essential documents, and support audits while promoting quality and patient-centered research.