Coordinator, Clinical Research Regulatory - Leukemia

Coordinator, Clinical Research Regulatory - Leukemia

MISSION STATEMENT
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education, and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2025-2026 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

Job Summary

We are seeking a highly motivated Regulatory Compliance Specialist to support clinical trial operations. This role is responsible for preparing and maintaining regulatory documentation, ensuring compliance with institutional and federal regulations, and facilitating communications between research teams, sponsors, and regulatory authorities.

Key Responsibilities

Regulatory Compliance

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs), Ethics Committees, and other regulatory bodies.

• Maintain accurate and up-to-date regulatory files and documentation.

• Ensure compliance with all applicable regulations, guidelines, and standards (e.g., FDA, GLP).

• Coordinate and manage the informed consent process for clinical trial participants.

• Liaise with clinical research teams, sponsors, and regulatory authorities to address regulatory issues and facilitate study approvals.

• Monitor and report on the status of regulatory submissions and approvals.

• Assist in the development and implementation of regulatory strategies for clinical trials.

• Provide training and support to clinical research staff on regulatory requirements and best practices.

• Stay current with changes in regulatory requirements and guidelines.

• Learn relevant processes for clinical trial development and IRB approval, including regulatory document maintenance.

• Ensure timely submission of all required regulatory and trial documentation.

• Participate in audits and reviews, including shadowing assignments.

• Support FDA submissions and participate in assigned research audits.

• Maintain schedules for timely protocol submissions to review boards.

• Manage a protocol portfolio of 1–8 clinical trials.

• Learn regulatory portal workflows and processes.

• Prepare and submit IND-related documents and oversee aspects of the FDA approval process.

• Communicate with sponsors regarding clinical trial regulatory document submissions.

• Collect and develop regulatory information for protocol submissions.

• Prepare for and participate in monitoring visits, ensuring timely and appropriate responses to sponsor and auditor queries.

• Support Protocol Teams in preparing for inspections by regulatory agencies.

• Coordinate appropriate staff coverage when absent.

Reporting & Documentation

• Enter data and maintain reports for research tracking and compliance purposes.

• Observe and support the assembly of regulatory documents per local and FDA regulations, institutional SOPs, and clinical trial processes (e.g., study activation, amendments).

• Create, update, and oversee the maintenance of current regulatory files for all Leukemia protocols.

• Respond to monitoring queries and audit findings as needed.

General Requirements

• Perform other duties as assigned.

• Comply with all institutional policies and regulatory standards.