Regulatory Affairs Coordinator

The US Oncology Network; Dallas (TX); Remote; USD 60,000 - 90,000; Full time

Job summary

A leading oncology network is seeking a Remote Research Regulatory Affairs Coordinator II to manage regulatory activities for clinical trials. This role involves document management, compliance, and collaboration with central operations, requiring strong communication skills and attention to detail. Ideal candidates will have relevant experience and educational qualifications, contributing to high-quality cancer care.

Qualifications

• 1+ year experience in clinical research regulatory affairs or oncology for Level 1.
• 3+ years experience for Level 2, Associate's preferred.
• 7+ years experience for Senior Level, Bachelor's preferred.

Responsibilities

• Assist with document collection and maintenance for trial openings.
• Collaborate to resolve regulatory issues and maintain compliance.
• Prepare informed consent documents and manage IRB submissions.

Skills

Communication

Multi-tasking

Attention to detail

Education

High school diploma

Associate's degree

Bachelor's degree

Tools

Microsoft Office

Job description

Overview

This position is based out of our corporate office in Dallas, Texas, and will support all TxO Locations.

Position Summary

The US Oncology Network is seeking a Remote Research Regulatory Affairs Coordinator II to join our team at Texas Oncology. This role supports all TxO locations and involves managing research regulatory and administrative activities for clinical trials.

About Texas Oncology

Texas Oncology is the largest community oncology provider in the U.S., with over 600 providers across 280+ sites in Texas. Our mission is to deliver high-quality, evidence-based cancer care using advanced technology and research, aiming for more breakthroughs and victories in patients' fights against cancer.

About The US Oncology Network

Supported by McKesson Corporation, it is one of the nation's largest networks of community-based oncology physicians dedicated to advancing cancer care in America.

Role Responsibilities

1. Assist with critical document collection and maintenance to facilitate trial openings and audit readiness.
2. Collaborate with central operations to resolve regulatory issues.
3. Maintain protocol regulatory documents in compliance with SOPs.
4. Manage Texas Oncology Research systems, ensuring proper access and troubleshooting issues.
5. Support quality improvement initiatives, assist with protocol and regulation compliance.
6. Prepare informed consent documents and regulatory packets for submissions.
7. Process IRB submissions and monitor/report SAEs.
8. Coordinate collection of site training documents and amendments.

Qualifications

Level 1: High school diploma, 1+ year experience in clinical research regulatory affairs or oncology.

Level 2: High school diploma (Associate's preferred), 3+ years experience.

Senior Level: Associate's degree (Bachelor's preferred), 7+ years experience.

Additional Skills: Proficiency in Microsoft Office, excellent communication, multi-tasking, high attention to detail, ability to work in a fast-paced environment.

Work Environment & Physical Requirements

Office setting, with requirements for extensive computer work, standing, walking, and occasional lifting up to 40 lbs. Accommodations available for disabilities.