Regulatory Coordinator Oncology Research

Oncology Voice Network LLC

Spring, Northern (TX, KY)

Hybrid

USD 60,000 - 80,000

Full time

9 days ago
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Job summary

Community Clinical Trials in Spring, TX seeks a Regulatory Coordinator to manage regulatory documents for oncology trials, ensuring compliance with all regulations and sponsor requirements.

The role collaborates with investigators, study teams, sponsors, and CROs to prepare IRB submissions, track timelines, maintain essential documents, and support audits while promoting quality and patient-centered research.

Qualifications

  • Experience with regulatory documentation and trial records.
  • Ability to interpret clinical research regulations and guidelines.
  • Understanding of regulatory requirements for oncology trials.
  • Experience managing regulatory submissions to IRBs, sponsors, and authorities.
  • Foundational knowledge of regulatory affairs in clinical research or healthcare.

Responsibilities

  • Prepare, submit, and maintain regulatory documents for oncology trials.
  • Coordinate IRB submissions and renewals and track timelines.
  • Maintain regulatory binders and essential documents.
  • Support start-up activities and sponsor/CRO regulatory queries.
  • Assist with SOP updates and regulatory best practices.

Skills

Regulatory documentation
Regulatory compliance
Regulatory requirements
Regulatory submissions
Regulatory affairs
Attention to detail
Written & verbal communication
Team collaboration

Tools

Office tools
Clinical trial management systems

Job description

# Regulatory Coordinator Oncology ResearchCommunity Clinical Trials · Spring, TXVisit company websiteFULL-TIMEPosted Sep 23, 2026## Job DescriptionCompany Description: Community Clinical Trials is a community-based oncology research network focused on expanding access to cutting-edge cancer clinical trials where patients receive their care. The organization partners with sponsors, CROs, healthcare systems, and community oncology practices to conduct high-quality research grounded in operational excellence, regulatory compliance, and patient-centered care. Experienced investigators and dedicated research teams work together to accelerate enrollment and increase access for diverse patient populations. By connecting innovative cancer therapies with local communities, Community Clinical Trials is advancing oncology research and helping shape the future of cancer care, one patient and one trial at a time. Role Description: The Regulatory Coordinator Oncology is a full-time, on-site role based in Spring, TX. This role is responsible for preparing, submitting, and maintaining regulatory documents for oncology clinical trials, ensuring compliance with applicable regulations, institutional policies, and sponsor requirements. Day-to-day tasks include coordinating IRB submissions and renewals, tracking regulatory timelines, maintaining regulatory binders and essential documents, and supporting study start-up activities. The Regulatory Coordinator will collaborate closely with investigators, research nurses, coordinators, sponsors, and CROs to address regulatory queries, support monitoring and audit visits, and help resolve compliance issues. This role also assists in implementing regulatory best practices, updating standard operating procedures, and contributing to a culture of quality and patient-centered research. Qualifications: • Candidates should possess skills in Regulatory Documentation and maintaining accurate, organized trial records. • Candidates should possess skills in Regulatory Compliance and interpreting applicable clinical research regulations and guidelines. • Candidates should possess skills in understanding and applying Regulatory Requirements for oncology clinical trials. • Candidates should possess skills in managing Regulatory Submissions to IRBs, sponsors, and regulatory authorities. • Candidates should possess foundational knowledge of Regulatory Affairs within clinical research or healthcare settings. • Experience in oncology clinical trials, academic or community research settings, or similar regulated environments is highly beneficial. • Strong attention to detail, organizational skills, and the ability to manage multiple studies and deadlines simultaneously. • Effective written and verbal communication skills, with the ability to collaborate across multidisciplinary teams. • Proficiency with standard office and electronic document management tools; experience with clinical trial management systems is a plus. • Relevant experience in oncology research strongly valued THIS IS AN ON-SITE POSITION. WE DO NOT SPONSOR VISAS.
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