Coordinator, Clinical Research Program (Regulatory) - Leukemia

Summary

The University of Texas MD Anderson Cancer Center is a cancer-focused institution dedicated to patient care, research, education, and prevention. The Coordinator, Clinical Research Program supports clinical research operations in the Department of Leukemia by overseeing protocol administration, regulatory compliance, trial coordination, training, reporting, and grant preparation.

Responsibilities

• Provide oversight of clinical research protocol development, administrative processing, and regulatory activities
• Collaborate with physicians, study chairs, and protocol sponsors regarding protocol design, planning, implementation, and evaluation
• Serve as liaison with research administration offices for protocol-related activities
• Ensure all clinical research conducted by the department complies with Institutional Review Board (IRB) and federal guidelines
• Maintain schedules for timely submission of new and revised protocols
• Provide clinical trial project oversight, strategic planning, and quality assurance for research conducted within the Department of Leukemia
• Collaborate with departmental personnel to maintain and improve protocol reference file systems for storing, retrieving, and accessing current protocols and correspondence
• Evaluate the effectiveness, accuracy, and training needs of the section
• Coordinate, plan, and oversee training programs while ensuring compliance with departmental standards
• Collect and develop criteria and process information for section and departmental approval and protocol submission
• Conduct orientation for faculty, trainees, and research/administrative support personnel
• Standardize training practices for protocol-related activities
• Provide direct and indirect oversight of research and faculty support staff involved in protocol setup, activation, monitoring, and reporting
• Systematically review and report on faculty assistant compliance with protocol-related job responsibilities
• Develop and maintain processing and tracking systems for protocol-related documentation
• Establish and participate in information systems supporting research program development
• Support protocol writing, processing, submission, and maintenance activities
• Prepare detailed and summary reports on section and departmental productivity and responsiveness
• Produce monthly, quarterly, and annual reporting related to protocol operations and research support activities
• Provide protocol and protocol-related information for grant applications in collaboration with department stakeholders
• Undertake and oversee clinical trial-related grant applications through public and private funding mechanisms
• Collaborate on large departmental grant applications as a preparation and production specialist
• Support the development of documentation and materials required for grant submission activities

Skills

• Bachelor's degree in a scientific, healthcare, business, public health, or related field
• Progressively responsible experience supporting clinical research programs, protocol administration, regulatory compliance, and clinical trial operations
• Expertise in coordinating complex research activities, managing protocol submissions and maintenance, ensuring compliance with Institutional Review Board (IRB) and federal regulations, developing reporting and tracking systems, supporting grant preparation efforts, and delivering training programs for research personnel
• Strong organizational, project management, analytical, communication, and stakeholder collaboration skills
• Highly detail-oriented, capable of managing multiple priorities in a fast-paced environment
• Bachelor's Degree
• Three years research study or direct patient care experience obtained from nursing, data gathering or other related experience or one year required experience with preferred degree
• May substitute required education degree with additional years of equivalent experience on a one to one basis
• Professional certifications related to clinical research administration or coordination
• Master's Degree Nursing, Public Health, Healthcare Administration or related scientific field

Qualifications

Must Haves

• bachelor's degree in a scientific, healthcare, business, public health, or related field
• progressively responsible experience supporting clinical research programs, protocol administration, regulatory compliance, and clinical trial operations
• expertise in coordinating complex research activities, managing protocol submissions and maintenance, ensuring compliance with Institutional Review Board (IRB) and federal regulations, developing reporting and tracking systems, supporting grant preparation efforts, and delivering training programs for research personnel
• strong organizational, project management, analytical, communication, and stakeholder collaboration skills
• highly detail-oriented, capable of managing multiple priorities in a fast-paced environment
• Bachelor's Degree
• Three years research study or direct patient care experience obtained from nursing, data gathering or other related experience or one year 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

• Professional certifications related to clinical research administration or coordination
• Master's Degree Nursing, Public Health, Healthcare Administration or related scientific field

Benefits

• Opportunities to work with leading faculty and research teams
• Opportunities to contribute to impactful clinical trials
• Opportunities to develop expertise in regulatory and protocol operations
• Remote work environment supporting work-life balance
• 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
• Medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition
• Relocation assistance available