Clinical Studies Coordinator Genitourinary Medical Oncology

UT MD Anderson is a leading institution focused on cancer care, research, education, and prevention. The Clinical Studies Coordinator plays a critical role in supporting clinical research activities that advance scientific discovery and improve patient outcomes.
Within GU Medical Oncology, the Clinical Studies Coordinator collaborates closely with physicians, research staff, and multidisciplinary teams to ensure protocol compliance, patient safety, and data integrity. The Clinical Studies Coordinator supports study operations from startup through closeout, while the Clinical Studies Coordinator helps maintain high standards of research quality and regulatory compliance across assigned studies.

The ideal candidate for the Clinical Studies Coordinator role will possess a strong foundation in clinical research operations, patient coordination, protocol compliance, and regulatory requirements. Experience supporting research studies, collaborating with multidisciplinary teams, maintaining accurate documentation, and communicating effectively with patients, sponsors, and healthcare professionals is highly desirable.

Why Us?
At UT MD Anderson, the Clinical Studies Coordinator contributes directly to groundbreaking clinical research that supports advancements in cancer care. This role offers opportunities to work alongside leading researchers and healthcare professionals while developing expertise in clinical trial management, regulatory compliance, patient coordination, and research operations in a mission-driven environment.
• Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
• Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
• Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

Responsibilities
Coordinate Clinical Research Studies
• Design, implement, monitor, and report clinical research project status to support on-time study performance
• Assess patient eligibility in consultation with physicians through interviews and medical record review
• Assist with informed consent processes for eligible research participants
• Review study protocols and develop systems for patient screening and visit scheduling
• Coordinate protocol-required study visits and activities
• Recruit and enroll patients accurately in assigned research protocols
• Consult regularly with Principal Investigators and Research Nurse Managers regarding study assignments
• Collaborate with research nurses, laboratory staff, and clinic personnel to support protocol execution
Manage Study Documentation & Patient Tracking
• Develop on-study notes and protocol-specific documentation as required
• Document study information accurately and timely within the electronic medical record
• Retrieve and evaluate information from electronic records, charts, and phone communications
• Schedule laboratory testing and protocol-required follow-up visits
• Track protocol time points, participant follow-up activities, and study milestones
• Maintain accurate records of patient participation and study-related activities
• Gather, evaluate, and report relevant patient and protocol information appropriately
Ensure Compliance, Quality & Data Integrity
• Track and document protocol deviations, violations, adverse events, and other study activities
• Maintain knowledge of clinical research databases and tools including CRF, CORe, Prometheus, GURU, Microsoft Office, and Excel
• Assist with analysis and quality assurance of clinical research information
• Coordinate routine study monitoring visits and audits with sponsors and clinical research organizations
• Respond accurately and promptly to sponsor, IND, and written research queries
• Support quality assurance efforts for non-investigator initiated trials to ensure data quality
• Advocate for clinical research processes in accordance with institutional, divisional, and departmental standard operating procedures and good Clinical Practice guidelines
Provide Education, Communication & Team Support
• Assist with training staff involved in IND and sponsored studies
• Serve as a preceptor and resource for research team members
• Provide protocol and compliance guidance to research personnel
• Communicate with investigators, protocol lead staff, and colleagues regarding deadlines and study activities
• Participate in research meetings and protocol-related discussions
• Demonstrate proactive oral and written communication with patients, sponsors, agencies, and external institutions
• Compose professional correspondence using gathered and analyzed information
• Independently prioritize and initiate weekly assignments with minimal supervision
• Communicate effectively with physicians and healthcare team members within and outside the institution
Support Research Administration & Operational Improvement
• Participate in continuing review submission processes in collaboration with trial managers and Principal Investigators
• Assist with preparation of Investigational New Drug reports, sponsor reports, and other required submissions
• Participate in protocol startup meetings and study closeout visits
• Contribute to the development of policies, procedures, and workflow processes that improve efficiency and effectiveness
• Support ongoing research administration activities as assigned
• Perform other duties as assigned