On-Site Regulatory Coordinator for Oncology Trials

Community Clinical Trials; Spring (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Community Clinical Trials is seeking a Regulatory Coordinator Oncology for an on-site role in Spring, TX. The candidate will prepare and maintain regulatory documents, coordinate IRB submissions, and ensure compliance with sponsor and regulatory requirements. Collaboration with investigators, nurses, sponsors, and CROs is essential.

The role emphasizes regulatory best practices, SOP updates, and contributing to a culture of quality and patient-centered research.

Qualifications

• Regulatory documentation and trial records must be accurate and organized.
• Ability to interpret clinical research regulations and guidelines.
• Understanding regulatory requirements for oncology trials.
• Experience submitting regulatory documents to IRBs, sponsors, and authorities.
• Foundational knowledge of regulatory affairs in clinical research.
• Experience in oncology trials or regulated healthcare settings is beneficial.
• Strong attention to detail and multi-study deadline management.
• Effective written and verbal communication across multidisciplinary teams.
• Proficiency with office tools; CTMS experience is a plus.
• On-site role in Spring, TX; visa sponsorship is not available.

Responsibilities

• Prepare, submit, and maintain regulatory documents for oncology clinical trials.
• Coordinate IRB submissions and renewals and track regulatory timelines.
• Maintain regulatory binders and essential documents; support start-up activities.
• Collaborate with investigators, research nurses, coordinators, sponsors, and CROs.
• Address regulatory queries and support monitoring and audit visits.
• Help implement regulatory best practices and update SOPs.

Skills

Regulatory Docs

Regulatory Compliance

Oncology Regulations

IRB Submissions

Regulatory Affairs basics

Oncology Trials Experience

Attention to detail

Communication Skills

Office Tools / CTMS

Oncology Research Experience

Tools

Clinical Trial Management Systems

Job description

Community Clinical Trials is seeking a Regulatory Coordinator Oncology for an on-site role in Spring, TX. The candidate will prepare and maintain regulatory documents, coordinate IRB submissions, and ensure compliance with sponsor and regulatory requirements. Collaboration with investigators, nurses, sponsors, and CROs is essential.

The role emphasizes regulatory best practices, SOP updates, and contributing to a culture of quality and patient-centered research.