NCI Specialist

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 primary purpose of the NCI Specialist position is to facilitate review and conduct of audits of NCI sponsored studies by assisting Investigators and research teams in complying with regulations, policies and procedures set forth by NCI, CIRB, and ETCN and NCTN grant requirements. The Specialist serves as the primary contact between NCI and MD Anderson’s research team and the subject matter expert as it relates to CIRB, ETCTN, NCTN and CTSU requirements.

The ideal candidate will have experience supporting NCI-sponsored clinical research programs, including ETCTN, NCTN, AMC, DCP, or NCORP trials. They will be proficient in using NCI systems, such as CTSU, Rave, and CIRB, and have experience with CAPA development, quality assurance reviews, and ensuring compliance with ICH-GCP guidelines and applicable federal regulations governing clinical research.

The ideal candidate will have a bachelor’s degree in a biological or science-related field or a professional nursing degree, along with at least three years of clinical research experience as a research nurse or study coordinator. Preferred candidates bring experience supporting NCI-sponsored clinical trials programs such as ETCTN, NCTN, AMC, DCP, or NCORP, proficiency in CTSU, Rave, and CIRB systems, and demonstrated expertise in CAPA development, quality assurance reviews, and compliance with ICH-GCP guidelines. A CCRP certification is also preferred.

Minimum $42.79 – Midpoint $53.37 – Maximum $63.94
Work Location: Texas Medical Center
Schedule: Hybrid; Onsite presence is required during audits, meetings and additional based on business needs.

Why Us?
This role offers the opportunity to directly impact clinical research that advances cancer treatment and patient outcomes on a national scale. At UT MD Anderson, team members are supported through meaningful work, professional development opportunities, and a collaborative environment that values work-life balance and innovation in research practices.
• 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
NCI Liaison
• Serve as primary communication liaison between research teams and NCI programs to facilitate protocol processes
• Submit Letters of Intent (LOI) and Project Team Member Applications (PTMAs) to NCI
• Coordinate communications with CTEP, CTSU, PMB, and network groups
• Manage communications and submissions to NCI Central IRB (CIRB)
• Participate in multicenter grant-specific and protocol-specific teleconferences
• Assist with study start-up including Site Initiation Visits and regulatory document review
• Submit required forms and documentation to CIRB
• Maintain lists of new and pipeline ETCTN projects and track enrollment, amendments, and progress
• Report project status updates to Grant Principal Investigator

Queries, Audit Responses, & Education
• Provide guidance on corrective measures to address audit findings using advanced oncology knowledge
• Interpret complex clinical research issues for investigators and research staff
• Identify quality improvement opportunities and support development of quality initiatives
• Conduct quality assurance reviews to ensure protection of human subjects and data integrity
• Ensure adherence to Good Clinical Practice guidelines, IRB requirements, and SOPs
• Organize and review essential and source documents prior to audit start dates
• Facilitate query responses and address urgent audit-related items in real time
• Develop and review Corrective and Preventive Action Plans (CAPA) with research teams and CRAs
• Prepare and submit audit-related reports to NCI groups

Quality Assurance
• Evaluate and support clinical research protocols developed through NCI programs
• Review source documentation against Rave system submissions
• Review Serious Adverse Event (SAE) reports and ensure submission timelines to CTEP

Additional Duties
• Perform other duties as assigned