Senior Coordinator, Clinical Research Program (Regulatory) - Leukemia

Senior Coordinator, Clinical Research Program - Leukemia

The University of Texas MD Anderson Cancer Center is a leading institution focused on cancer care, research, education, and prevention. The Clinical Research Program supports the advancement of clinical research within the Leukemia program by coordinating complex regulatory, administrative, financial, and operational activities associated with clinical trials.

The Clinical Research Program Senior Coordinator serves as a key resource for investigators, sponsors, and research teams to ensure protocol compliance, study activation, and successful trial execution. They contribute to the delivery of high-quality clinical research that supports UT MD Anderson's mission to eliminate cancer through exceptional programs in patient care, research, education, and prevention.

The ideal candidate will possess a Master's degree in Nursing, Public Health, Healthcare Administration, or a related scientific field, along with significant experience in research studies, clinical research administration, direct patient care, nursing, data gathering, or a related field. Candidates with experience managing regulatory submissions, protocol development, investigator support, clinical trial start-up activities, sponsor collaboration, compliance oversight, and clinical research operations will be well suited for this role.

Hourly Salary Range (40-hour work week):
Minimum $32.21 – Midpoint $40.14 – Maximum $48.08

Work Location:

Remote

• Manage administrative and regulatory aspects of federal and pharmaceutical-funded research protocols through all study phases
• Provide administrative support to Principal Investigators for study development, implementation, and completion
• Independently prepare protocol documents that comply with regulatory and institutional requirements
• Collaborate with sponsors and Clinical Research Organizations to develop budget documents meeting institutional and sponsor requirements
• Submit protocols for Clinical Research Committee and Institutional Review Board review
• Respond on behalf of Principal Investigators to reviewer comments when appropriate
• Coordinate site start-up activities and oversee overall financial trial management
• Assist with preparation of responses to Clinical Research Committee and Institutional Review Board reviews
• Serve as liaison with pharmaceutical sponsors regarding informed consent document language
• Develop and maintain tracking systems, status reports, regulatory files, and organizational records for clinical trials

• Review protocols, amendments, and ancillary documents to identify discrepancies and clarify requirements
• Collaborate with investigators and sponsors to resolve protocol-related issues
• Prepare and submit reports to sponsors, investigators, regulatory authorities, and management
• Support strategic and long-range planning for departmental clinical trial programs
• Coordinate weekly clinical research review meetings and ad hoc protocol review meetings
• Partner with clinical faculty to support departmental clinical trial goals
• Ensure all protocol reviews are addressed to the satisfaction of reviewers
• Manage new protocol start-up processes and study activation requirements

• Attend training related to clinical trial documentation, regulatory requirements, and departmental procedures
• Maintain compliance with Good Clinical Research Practice standards
• Create presentations and visual aids addressing regulatory aspects of clinical research administration
• Assist with educational programs and in-service training for faculty and staff
• Communicate regulatory and protocol-related updates to team members
• Participate in the development of departmental clinical research policies and procedures
• Support development of in-service educational events for team members
• Maintain current knowledge of clinical trial processes and regulatory requirements
• Orient new faculty and support personnel to clinical research infrastructure and procedures

• Monitor protocol start-up activities and ensure laboratory personnel…