Senior Coordinator, Clinical Research Program (Regulatory) - Leukemia

UT MD Anderson Cancer Center • Houston, TX

1d • $32 - $48 • Remote

About The Position

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.

Requirements

• Bachelor's Degree
• Five years experience in research study or direct patient care obtained from nursing, data gathering or related field or three years required experience with preferred degree.
• May substitute required education degree with additional years of equivalent experience on a one-to-one basis.

Nice To Haves

• Master’s degree in Nursing, Public Health, Healthcare Administration, or a related scientific field
• Experience managing regulatory submissions
• Experience with protocol development
• Experience with investigator support
• Experience with clinical trial start-up activities
• Experience with sponsor collaboration
• Experience with compliance oversight
• Experience with clinical research operations

Responsibilities

• 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 understand assigned responsibilities
• Participate in site initiation visits to clarify sample collection, processing, and shipment requirements
• Create study collection sheets according to protocol specifications
• Submit and manage protocol amendments, updates, and regulatory documentation
• Coordinate protocol implementation activities between investigators, laboratories, and research teams
• Develop and maintain processing and tracking systems for protocol-related documentation
• Establish and participate in systems supporting protocol development, submission, processing, and maintenance
• Generate monthly, quarterly, and annual productivity and responsiveness reports
• Provide protocol-related information and data for grant applications
• Manage clinical trial-related grant applications through public and private funding mechanisms
• Collaborate on departmental grant applications as a preparation and production

Benefits

• Employer-paid medical coverage starting day one for employees working 30+ hours/week
• Optional group dental, vision, life, AD&D, and disability insurance
• Accruals for PTO and Extended Illness Bank
• Paid holidays
• Wellness, childcare, and other leave options
• Tuition Assistance Program after six months of service
• Access to extensive wellness, fitness, and employee resource groups
• Defined-benefit pension through the Teachers Retirement System
• Voluntary retirement plans
• Employer-paid life and reduced salary protection programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior