Clinical Trial Coordinator

The Division of Clinical Research provides infrastructure support for all aspects of clinical research. UT MD Anderson has the nation's largest cancer clinical trials program enrolling patients in Texas and beyond through our Cancer Network® partners across the country. UT MD Anderson is devoted to the needs and protection of all those participating in or conducting clinical research while maintaining high ethical standards and compliance with all regulatory policies. The Clinical Trial Laboratory Coordinator is a key expert in clinical research laboratory operations, ensuring high-quality protocol execution, compliance, and efficiency. This role involves protocol development and quality assurance, including creating and maintaining protocol documents, utilizing the LIMS system (ARMADA), and ensuring compliance with regulatory requirements. The coordinator oversees specimen collection, processing, and shipment, ensuring adherence to Good Clinical Laboratory Practices (GCLP) and troubleshooting issues as needed. Additionally, they manage clinical trial inventory and service coordination, maintaining trial kit supplies and facilitating communication between lab staff, study teams, and sponsors. Lastly, they play a crucial role in trial management and stakeholder collaboration, leading protocol implementation, overseeing amendments, and ensuring seamless interactions with sponsors and regulatory bodies. Through expertise in laboratory operations and research coordination, this position enhances the integrity and efficiency of clinical trials. The ideal candidate will have clinical research or laboratory operations experience and demonstrated ability to review and interpret clinical protocols, laboratory manuals, amendments, and study‑related documentation. Strong attention to detail, organizational skills, and knowledge of clinical research processes and regulatory requirements are highly preferred. Minimum $27.64 - Midpoint $34.62 - Maximum $41.59 per hour based on a 40-hour work week. The typical work schedule is Hybrid, 8:00am-4:30pm Work location is the Texas Medical Center. Why Us? This role offers the opportunity to support groundbreaking cancer research while working within a collaborative, mission‑driven environment at UT MD Anderson. The position contributes directly to patient safety, research quality, and scientific advancement, while providing exposure to complex clinical trials, regulatory engagement, and cross‑functional leadership. UT MD Anderson supports professional growth, operational excellence, and work‑life balance through a hybrid schedule and robust institutional resources. 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 Trial Management & Stakeholder Collaboration Lead protocol execution, conduct quality assurance audits, participate in monitor visits, and maintain protocol integrity. Manage new protocol start‑ups, attend site initiation visits, and develop collection sheets per protocol. Collaborate with sponsors on protocol updates, amendments, kit updates, and compliance requirements. Train and inform laboratory personnel on protocol changes to ensure standardized processes. Protocol Development & Quality Assurance Assist with protocol analysis, budget preparation, and regulatory compliance activities. Develop and maintain protocol documents to ensure alignment across research teams, sponsors, and external agencies. Review and approve laboratory manuals, collection kits, and supporting documentation for compliance. Utilize the LIMS system (ARMADA) for protocol tracking, documentation, and updates. Specimen Collection, Processing & Shipment Oversight Provide oversight and training related to specimen collection, including phlebotomy, urine, tissue, and EKGs as needed. Ensure accurate specimen labeling, documentation, and adherence to Good Clinical Laboratory Practices. Oversee quality assurance and quality control checks, specimen integrity, packaging, tracking, and shipment logistics. Troubleshoot specimen collection or shipment issues with vendors and study teams. Clinical Trial Inventory & Service Coordination Maintain and track clinical trial kit inventory to ensure timely replenishment. Share protocol details with Central Laboratory staff, research teams, and monitors. Develop training materials and communication tools to support protocol implementation. Provide operational leadership to ensure seamless collaboration across laboratory, research, and sponsor teams. Other Duties Perform other duties as assigned and support departmental goals through initiative and adaptability EDUCATION Required: Bachelor's Degree in Public Health, Healthcare Administration, or related scientific field Preferred: Master's Degree in Public Health, Healthcare Administration, or related scientific field Work Experience Required: Two years of experience with clinical research studies obtained from data gathering, laboratory, or other related experience or with a preferred degree, no experience required Preferred: Experience working in clinical research, laboratory operations, or a similar environment is preferred. Prior experience reading clinical protocols, laboratory manuals, amendments, and study‑related documentation is highly preferred. May substitute required education degree with additional years of equivalent experience on a one‑to‑one basis LICENSES AND CERTIFICATIONS Preferred: Certification issued by the American Society for Clinical Pathology (ASCP), including but not limited to Phlebotomy (PBT), Medical Laboratory Technician (MLT), Medical Laboratory Assistant (MLA) Preferred: CCRC - Certified Clinical Research Coordinator Preferred: CCRP - Certified Clinical Research Professional Preferred: CCRA - Certified Clinical Research Associate 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. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law. Additional Information Requisition ID: 182864 Employment Status: Full-Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 57,500 Midpoint Salary: US Dollar (USD) 72,000 Maximum Salary : US Dollar (USD) 86,500 FLSA: non-exempt and eligible for overtime pay Fund Type: Soft Work Location: Hybrid Onsite/Remote Pivotal Position: No Referral Bonus Available?: No Relocation Assistance Available?: No #J-18808-Ljbffr