The University of Texas MD Anderson Cancer Center is home to the Colon & Rectal Surgery Research team, which supports innovative clinical research studies focused on advancing patient care through protocol-driven research, data management, regulatory compliance, and multidisciplinary collaboration. This team works closely with principal investigators, physicians, research nurses, sponsors, and patients to ensure the successful execution of clinical trials and research initiatives.
The Senior Clinical Research Coordinator plays a critical role in supporting clinical studies while ensuring compliance with regulatory requirements and maintaining the highest standards of patient-centered research. The Senior Clinical Research Coordinator serves as a key resource for protocol management, and the Senior Clinical Research Coordinator helps drive research quality, patient engagement, and study success.
The ideal candidate will have experience as a clinical study coordinator with significant patient-facing research responsibilities, including informed consenting and protocol management. Preferred qualifications include familiarity with investigator-initiated trials (IIT), cell therapy, National Cancer Institute (NCI) clinical trials, and research biospecimens. Education and licensure requirements were not provided; therefore, candidates should possess the experience and skills necessary to independently manage complex clinical research protocols.
Salary: Minimum $67,000 - Midpoint $83,500 - Maximum $100,000
Work Location: Hybrid, onsite as needed (~3 days/week)
Key Responsibilities
Protocol Management
• Assume responsibility for the effective management and operation of research protocols in collaboration with the Principal Investigator and study sponsor
• Independently perform protocol-related activities including patient screening, consenting, scheduling, retention, specimen collection, monitoring, and evaluation of patient responses
• Review patient eligibility with research nurses and physicians through interviews and medical record review in outpatient and inpatient settings
• Communicate with investigators and clinical teams to confirm eligibility and support protocol enrollment decisions
• Read protocols and develop systems for screening, scheduling, recruitment, and eligibility verification
• Assess patients during follow-up visits according to protocol requirements
• Develop on-study notes, protocol-specific documentation tools, and supporting research documents
• Collaborate with multidisciplinary teams to support study execution and patient care
• Maintain required documentation in medical records and recruitment logs in accordance with protocol and institutional standards
• Manage day-to-day regulatory activities including delegation of authority logs, serious adverse events, deviations, violations, and continuing reviews
Data Management & Monitoring
• Maintain protocol documentation and quality control using paper files, electronic files, study databases, and electronic data entry systems
• Prepare and maintain prospective patient databases and enter clinical data throughout treatment and study participation
• Develop and maintain systems for processing and tracking protocol-related documentation
• Collect, evaluate, and accurately enter protocol-related data into databases and case report forms
• Maintain comprehensive and compliant patient records according to state, institutional, and study requirements
• Track protocols, amendments, external safety reports, and continuing reviews within study databases
• Compile and submit data supporting manuscripts, abstracts, journals, and posters as requested by faculty
• Generate protocol queries, reports, and monthly project updates for investigators, managers, and directors
• Prepare for internal and external audits and ensure patient documentation is complete and accessible
• Participate in departmental audits and educational quality assurance activities to maintain audit readiness
Collaboration & Development
• Participate in pre-submission protocol reviews and provide feedback on design, logistical, and clinical considerations
• Assist with the development of departmental resources, training materials, policies, and procedures related to clinical trial conduct
• Support onboarding, orientation, and ongoing training of research personnel through group and individual sessions
• Provide preceptee feedback to management during onboarding and retraining activities
• Assist with cross-department biospecimen collection and delivery across campus
• Serve as a backup for biological sample procurement, including tissue and blood collection activities
• Deliver collected samples to laboratories for processing and maintain sample handling standards
• Adhere to safety guidelines and appropriate sterile techniques during sample collection
• Collaborate with research and laboratory teams to resolve sample inventory and invoice-related issues
Institutional Compliance & Professional Engagement
• Coordinate protocol development, implementation, and completion while ensuring regulatory compliance with applicable laws, policies, and procedures
• Demonstrate knowledge of the research process, Code of Federal Regulations, and International Council for Harmonisation Good Clinical Practice guidelines
• Support submission of external safety reports to the Institutional Review Board within required timelines
• Provide protocol summary reports and research updates as requested
• Obtain appropriate approvals before implementing permanent or substantial work assignment changes
• Remain current on research, oncology, and data management developments through professional education and training
• Attend departmental research meetings, conferences, and educational sessions
• Educate professional and ancillary staff on research protocols through presentations and in-service training
• Provide accurate protocol information to the multidisciplinary team
• Complete all mandatory institutional training requirements and perform other duties as assigned
EDUCATION- Required: Bachelor's Degree
- Preferred: Master's Degree Public Health or related scientific field.
WORK EXPERIENCERequired: 5 years Experience in research study or direct patient care obtained from nursing, data gathering or related field or 3 years Required experience with preferred degree. May substitute required education degree with additional years of equivalent experience on a one to one basis.
Preferred: Experienced clinical study coordinator
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
