Remote Regulatory Affairs Coordinator II - All TxO Locations

US Oncology Network-wide Career Opportunities; Town of Texas, Dallas (WI, TX); Remote; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Remote Research Regulatory Affairs Coordinator II to manage regulatory activities for clinical trials. This role involves preparing essential protocol documents, ensuring compliance with regulations, and supporting quality initiatives. Join a team dedicated to delivering high-quality cancer care and making breakthroughs in treatment accessible to communities. If you have experience in clinical research and a passion for improving patient outcomes, this is an exciting opportunity to make a meaningful impact in the oncology field.

Qualifications

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

Responsibilities

• Manage regulatory and administrative activities of clinical trials.
• Prepare protocol documents and handle IRB submissions.

Skills

Clinical Research

Regulatory Affairs

Communication Skills

Multitasking

Time Management

Education

High School Diploma

Associate's Degree

Tools

Microsoft Office

Job description

Overview

The US Oncology Network is looking for a Remote Research Regulatory Affairs Coordinator II 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 over 600 providers across more than 280 sites in Texas. Our mission is to make the best cancer care accessible to all communities, enabling patients to fight cancer at home with support from family and friends. We utilize leading technology and research to achieve "More breakthroughs. More victories." in cancer treatment.

What does the Remote Research Regulatory Affairs Coordinator do?

This role, under minimal supervision, manages the research regulatory and administrative activities of clinical trials. Responsibilities include preparing protocol documents, ensuring compliance with regulations and SOPs, leading quality improvements, and supporting site research quality in accordance with USOR and Texas Oncology standards, GCP, and applicable laws.

Responsibilities

• Assist with critical document collection and maintenance for trial readiness and audits.
• 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 quality initiatives and help investigators with protocols and regulations.
• Prepare informed consent documents and regulatory packets for submissions.
• Handle IRB submissions and monitor/report SAEs.
• Collect and coordinate training documents from study initiation and ongoing amendments.

Qualifications

• High School Diploma required; Associate's degree preferred.
• At least three years of experience in clinical research, regulatory affairs, or oncology-related fields.
• Proficiency in Microsoft Office.
• Experience with sponsor monitor interactions preferred.
• Excellent communication, multitasking, and time management skills.