Clinical Trials Activation Coordinator

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 Trials Activation Coordinator ensures compliance for clinical research studies. The role involves coordination of the study feasibility review process to ensure the successful selection, review, and start-up of clinical trials. Responsibilities include preparing and maintaining regulatory documents, completing sponsor required documents, facilitating the CDA completion process, communicating with sponsors, faculty and study teams, providing local policies, site selection meetings, and collaborating with internal partners to facilitate timely study feasibility review. Responsibilities Serve as primary liaison for feasibility review processes for Phase I-V clinical trials. Analyze study feasibility documentation and requirements for investigator review. Interpret and apply FDA regulations, NCI policies, and Good Clinical Practice guidelines. Maintain regulatory documentation and source records in designated systems. Ensure compliance with federal, state, and local clinical research regulations. Collaborate with research teams, sponsors, and regulatory leaders to resolve start-up issues. Coordinate with sponsors or CROs to address feasibility and activation queries. Communicate feasibility status updates to leadership and key stakeholders. Facilitate site selection meetings and document collection. Monitor and report study status throughout feasibility and start-up phases. Stay current with evolving regulatory requirements and clinical research guidelines. Provide education and guidance to stakeholders on research processes and compliance. Review and optimize study start-up workflows for efficiency and communication. Promote standardized processes to ensure high-quality research outcomes. Maintain accurate and up-to-date regulatory documentation and standard operating procedures. Ensure adherence to institutional policies and documentation standards. Utilize systems such as CTMS and IRB platforms to manage study workflows. Qualifications Required: Bachelor's degree. Preferred: Master's degree. Required: One year experience in regulatory compliance or quality assurance. Preferred: Experience with feasibility reviews and clinical trial start-up activities. May substitute education degree with additional years of experience on a one-to-one basis. Preferred certifications: CCRP-Certified Clinical Research Professional, CCRC-Certified Clinical Research Coordinator, CHRC-Certified in Healthcare Research Compliance. Benefits 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. Equality and diversity are core values. The University of Texas MD Anderson Cancer Center provides 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. Further policies can be found at #J-18808-Ljbffr University of Texas MD Anderson Cancer Center