Coordinator, Clinical Research Program (Regulatory) - Leukemia

UT MD Anderson Cancer Center • Houston, TX

20h • Remote

About The Position

The University of Texas MD Anderson Cancer Center is a world-renowned institution dedicated to cancer patient care, research, education, and prevention. Within the Department of Leukemia, the Coordinator, Clinical Research Program supports complex clinical research operations that advance innovative therapies and improve outcomes for patients with leukemia. The Coordinator, Clinical Research Program plays a critical role in protocol administration, regulatory oversight, and research program coordination. UT MD Anderson provides an environment where clinical research excellence, collaboration, and continuous improvement are central to its mission. The Coordinator, Clinical Research Program works closely with physicians, study chairs, protocol sponsors, and research staff to ensure clinical trials are developed, activated, managed, and maintained in compliance with institutional and regulatory requirements. The Coordinator, Clinical Research Program also contributes to training, quality assurance, reporting, and grant preparation activities that support departmental research goals. The ideal candidate will have a bachelor’s degree in a scientific, healthcare, business, public health, or related field, along with progressively responsible experience supporting clinical research programs, protocol administration, regulatory compliance, and clinical trial operations. Candidates should demonstrate 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. Professional certifications related to clinical research administration or coordination are valued, along with strong organizational, project management, analytical, communication, and stakeholder collaboration skills. The successful candidate will be highly detail-oriented, capable of managing multiple priorities in a fast-paced environment, and committed to supporting the research mission of The University of Texas MD Anderson Cancer Center through effective coordination of clinical research programs within the Department of Leukemia.

Requirements

• 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
• Expertise in managing protocol submissions and maintenance
• Expertise in ensuring compliance with Institutional Review Board (IRB) and federal regulations
• Expertise in developing reporting and tracking systems
• Expertise in supporting grant preparation efforts
• Expertise in delivering training programs for research personnel
• Strong organizational skills
• Strong project management skills
• Strong analytical skills
• Strong communication skills
• Strong stakeholder collaboration skills
• Highly detail-oriented
• Capable of managing multiple priorities in a fast-paced environment
• 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 are valued
• Master's Degree Nursing, Public Health, Healthcare Administration or related scientific field.

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

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: Mid Level