Regulatory Affairs Coordinator

Texas Oncology; Dallas (TX); Remote; USD 65,000 - 85,000; Full time

Job summary

Texas Oncology seeks a Remote Research Regulatory Affairs Coordinator II to manage regulatory processes for clinical trials. The role involves ensuring compliance with SOPs and regulations, preparing documents, and collaborating with operations. Ideal candidates have experience in clinical research, excellent communication, and multitasking skills.

Qualifications

• 1 year experience in clinical research regulatory affairs preferred.
• 3 years experience in clinical research or regulatory affairs for Level 2.
• 7 years relevant experience for Senior level.

Responsibilities

• Assist with collection and maintenance of critical documents for trials.
• Manage Texas Oncology Research systems and ensure compliance.
• Prepare informed consent documents and process IRB submissions.

Skills

Communication

Multitasking

Time Management

Interpersonal Skills

Attention to Detail

Education

High school diploma

Associate's degree

Bachelor'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 provides 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. 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 dedicated to advancing cancer care in America. It is supported by McKesson Corporation, focused on empowering a sustainable community patient care delivery system to advance science, technology, and quality of care.

What does the Remote Research Regulatory Affairs Coordinator do?

This position, under minimal supervision, is responsible for research regulatory and administrative activities related to clinical trials. It manages regulatory processes and procedures, prepares protocol documents complying with regulatory and institutional requirements, and leads quality improvement initiatives. Ensures research site quality by adhering to US Oncology Research, Inc. (USOR) and Texas Oncology Research SOPs, GCP principles, and applicable regulations including OSHA, CDC, and HIPAA. Supports US Oncology Compliance Program, including the Code of Ethics Business Standards.

Responsibilities

• Assist with collection and maintenance of critical documents to facilitate trial openings and audit readiness.
• Collaborate with central operations to resolve regulatory issues.
• Maintain Protocol Regulatory Documents in compliance with SOPs.
• Manage Texas Oncology Research systems, ensuring proper access and troubleshooting issues.
• Assist with QA initiatives and develop quality improvement measures.
• Prepare informed consent documents and regulatory packets for submissions.
• Process IRB submissions and monitor/report SAEs.
• Coordinate collection of site training documents during study initiation and ongoing amendments.

Qualifications

The ideal candidate will have the following background and experience:

Level 1 Qualifications

• High school diploma or equivalent; some college coursework preferred.
• At least one year of experience in clinical research regulatory affairs or oncology-related fields.

Level 2 Qualifications

• High school diploma required; associate's degree preferred.
• Minimum 3 years of experience in clinical research, regulatory affairs, or oncology.

Level Sr Qualifications

• Associate's degree required; bachelor's preferred.
• At least seven years of relevant experience.

Business Experience

• Proficiency in Microsoft Office.
• Experience working with sponsor monitor representatives.

Skills and Knowledge

• Experience in clinical research preferred.
• Excellent communication, multitasking, and time management skills.
• Strong interpersonal skills and attention to detail.
• Ability to work in a fast-paced environment.

Working Conditions

Environment: Office setting, typical outpatient clinic environment, with exposure to communicable diseases, toxic substances, etc. Physical: Extensive computer work, standing, walking, occasional lifting up to 40 lbs., normal vision and hearing required.