Coordinator, Research Data - GI Medical Oncology

The University of Texas MD Anderson Cancer Center is dedicated to eliminating cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research, prevention, and education. The Department of GI Medical Oncology's UGI (Gastric and Esophageal) Cancer Program conducts clinical research focused on advancing treatments and improving outcomes for patients with gastrointestinal cancers. The Research Data Coordinator supports these efforts through clinical trial coordination, data management, and patient-focused research activities.

The Research Data Coordinator plays an essential role in supporting clinical research operations within the UGI Cancer Program. The Research Data Coordinator works closely with research nurses, investigators, sponsors, and protocol patients to ensure accurate data collection, protocol compliance, and efficient study execution. The Research Data Coordinator contributes directly to the success of clinical trials and the advancement of cancer research at UT MD Anderson.

The ideal candidate will have experience supporting clinical research studies with a strong background in clinical trial documentation, protocol management, audit preparation, data collection, and research coordination. Candidates should possess excellent organizational and data management skills, attention to detail, and the ability to manage multiple priorities. Phlebotomy experience or a willingness to complete training is preferred.

Responsibilities

Clinical Research Coordination

• Coordinate communication between research nursing staff and protocol patients through telephone outreach.
• Assist with scheduling protocol-related appointments, tests, and procedures.
• Verify patient schedules for accuracy and timeliness.
• Support research study coordination activities within the UGI Cancer Program.
• Participate in continuing education programs, conferences, workshops, and institutional training.
• Participate in formal and informal instruction of nurses and healthcare professionals regarding clinical research trials.

Data Collection & Data Management

• Coordinate and maintain systems for protocol and non-protocol study data collection.
• Maintain research files and records that are organized and accessible to authorized personnel.
• Computerize research files and tracking systems for reporting and monitoring purposes.
• Review research data for accuracy and completeness with registered nurse oversight.
• Collect research information and accurately log data into applicable databases.
• Maintain tracking systems to support study documentation and regulatory compliance.

Audit & Regulatory Support

• Assist research nurses with internal and external research audits.
• Review research data for accuracy and make corrections with registered nurse oversight.
• Review, classify, file, and purge research information according to established procedures.
• Maintain schedules for timely submission of data to funding sources and internal review committees.
• Develop, organize, and maintain protocol binders for active studies.
• Maintain audit-ready research documentation and records.

Monitoring, Documentation & Research Support

• Coordinate monitor visits for active clinical studies.
• Assist with study startup meetings and related preparation activities.
• Prepare case report forms for completion prior to monitor visits.
• Perform corrections to case report forms with registered nurse oversight.
• Accurately transcribe research data into case report forms with five or fewer errors per page.
• Ensure accurate documentation of serious adverse events, non-serious adverse events, and concomitant medications.
• Obtain outside medical records and verify records are complete, readable, and accurate.
• Review outside laboratory results for protocol-required accuracy and completeness.
• Establish and maintain systems for tracking CLIA certifications and laboratory logs.

Research Operations & Specimen Management

• Train support staff on study coordination activities, policies, procedures, and clinical trial audit requirements.
• Obtain pathology slides from outside institutions or within the organization according to institutional guidelines.
• Register protocols on Tissue Station as required by institutional policy.
• Collect research blood samples and research tissue specimens according to protocol requirements.
• Package and ship research tissue specimens to sponsors or certified laboratories using approved biological material handling procedures.
• Perform research charge capture activities and submit research charges within 24 to 48 hours of procedures or testing.
• Verify research procedures are ordered according to protocol requirements.
• Verify research procedures are coded appropriately as standard of care or research-covered services based on protocol coverage analysis.
• Perform phlebotomy procedures or complete required phlebotomy training.
• Perform other duties as assigned.

EDUCATION

• Required: High School Diploma or Equivalent
• Preferred: Bachelor's Degree

WORK EXPERIENCE

• Required: Two years related experience or no experience required with preferred degree.