Regulatory Coordinator

Responsibilities

Have knowledge and represent the research program in all regulatory affair requirements, interacting with local, state and federal agencies

Submissions of regulatory documents including but not limited to: initial IRB forms, 1572 forms, financial disclosures, annual reviews, amendments, investigational new drug applications, device related trial submissions, safety reports, and continuing reviews. Track submissions and ensure timely filing of documents

Responsible for organizing and maintaining up to date clinical trial information, including study protocols and informed consent forms, for accurate presentation to physicians and study staff to ensure patient safety

Directly communicates with sponsors, study staff and Institutional Review Board Coordinators as it relates to study specific document modifications and Institutional Review Board requested revisions

Tracking staff training to all applicable regulatory requirements including but not limited to GCP, Human subjects’ protection, hazmat ( IATA) training, and all study specific related training

Help to create/develop CCNW standard operating procedures to ensure staff understanding of required compliance and research participant safety

Must be detail-oriented and be able to multi-task to meet standard response times and deadlines

Must be able to demonstrate appropriate conflict resolution in stressful situations

Demonstrate superior customer service skills

Demonstrate the ability to work independently and as part of a team

Any other duty as assigned

Preferred

Regulatory experince in clinical research

Oncology experience

Every day, The US Oncology Network helps approximately 3,300 providers deliver value-based, integrated care for patients—close to home.

The Woodlands, Texas, USA

http://www.usoncology.com/

Late Stage

Total Funding

unknown

2010-12-30

Acquired

Recent News

Business Wire

Research Presented by The US Oncology Network Demonstrates How Community Practices Are Expanding Patient Access Through APP‑Led Models at ASCO 2026

2026-05-29

PR Newswire

29 Physicians from Virginia Cancer Specialists Named to Washingtonian Magazine's Top Doctors List 2025

2025-10-27

DeepScribe Solidifies Ambient AI Leadership in Oncology with New Study and Accelerated Growth

2025-09-17

Company data provided by

Qualifications

Bachelor's degree or equivalent combination of education and experience

Proficient with Microsoft Office

Regulatory experince in clinical research

Oncology experience

Required skills

Microsoft Office, Clinical Research Regulatory Affairs, Oncology

Preferred skills

Regulatory experince in clinical research, Oncology experience, The Woodlands, Texas, USA, http://www.usoncology.com/, Late Stage, Total Funding, unknown, 2010-12-30, Acquired, Recent News, Business Wire, 2026-05-29, PR Newswire, 2025-10-27, 2025-09-17, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

Mid level