Remote Research Regulatory Affairs Coordinator - All TxO Locations

US Oncology Network-wide Career Opportunities; Town of Texas, Dallas (WI, TX); Remote; USD 40,000 - 80,000; Full time

Job summary

Join a forward-thinking organization dedicated to advancing cancer care as a Remote Research Regulatory Affairs Coordinator. In this vital role, you will manage regulatory activities for clinical trials, ensuring compliance with institutional requirements and supporting quality improvement initiatives. Collaborate with a dedicated team to prepare essential documents and maintain trial readiness, all while contributing to the mission of making cancer care accessible to communities. If you're passionate about making a difference in patients' lives and have experience in clinical research or regulatory affairs, this is the perfect opportunity for you.

Qualifications

• 1+ years of experience in clinical research or regulatory affairs.
• Proficiency in Microsoft Office and excellent multitasking skills.

Responsibilities

• Manage research regulatory activities for clinical trials.
• Assist with document collection and maintain trial readiness.
• Collaborate with operations to resolve regulatory issues.

Skills

Clinical Research

Regulatory Affairs

Communication Skills

Time Management

Microsoft Office

Education

High School Diploma

Associate's Degree in Clinical or Scientific Field

Job description

Overview

The US Oncology Network is looking for a Remote Research Regulatory Affairs Coordinator to join our team at Texas Oncology! This position is based out of our corporate office in Dallas, Texas, and will support all TxO Locations.

As part of The US Oncology Network, Texas Oncology delivers high-quality, evidence-based care to patients close to home. It is the largest community oncology provider in the country, with approximately 600+ providers across 280+ sites in Texas. Our mission is to make the best available cancer care accessible to all communities, enabling patients to fight cancer at home with support from family and friends. We use leading-edge technology and research to achieve "More breakthroughs. More victories." for our patients. Today, Texas Oncology treats half of all Texans diagnosed with cancer annually.

The US Oncology Network is one of the nation's largest networks of community-based oncology physicians, supported by McKesson Corporation, dedicated to advancing cancer care through a sustainable community delivery system.

What does the Remote Research Regulatory Affairs Coordinator do?

This position, under minimal supervision, manages research regulatory and administrative activities for clinical trials. It involves preparing protocol documents compliant with regulatory and institutional requirements, ensuring site research quality, and practicing in accordance with US Oncology Research, Inc. (USOR) and Texas Oncology SOPs, GCP principles, and applicable regulations. The role also supports US Oncology Compliance Program and the Code of Ethics Business Standards.

Responsibilities

• Assist with critical document collection and maintenance for trial readiness and audit preparedness.
• Collaborate with central operations to resolve regulatory issues.
• Maintain Protocol Regulatory Documents per SOPs.
• Manage Texas Oncology Research systems, ensuring access and troubleshooting issues.
• Support local QA initiatives and lead quality improvement measures.
• Assist with preparation of informed consent documents and regulatory packets for submissions.
• Handle local and central IRB submissions.
• Monitor and report SAEs to sponsors and IRBs.
• Coordinate collection of site training documents at study initiation and ongoing amendments.

Qualifications

• High School Diploma required.
• Associate's degree in a clinical or scientific field preferred.
• At least one year of experience in clinical research, regulatory affairs, or oncology-related fields required.
• Proficiency in Microsoft Office.
• Experience with Sponsor Monitor interactions preferred.
• Excellent communication, multitasking, and time management skills required.