Regulatory Coordinator Oncology Research

Company 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.