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Clinical Trials Activation Coordinator

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Audit / Compliance
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Clinical Trials Start-Up 710838
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181720 Requisition #
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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.

This Clinical Trials Activation Coordinator ensures compliance for clinical research studies. Involves coordination ofstudy 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.

The ideal Clinical Trials Activation Coordinator will have experience with feasibility reviews and clinical trial start-up activities.

Minimum $29.09 – Midpoint $36.30 – Maximum $43.51
Work Location: Remote

Why Us?
UT MD Anderson offers the opportunity to contribute to one of the nation’s largest clinical trials programs, directly impacting patient care and research innovation. This role supports professional growth through exposure to regulatory processes, cross-functional collaboration, and continuous learning, while promoting a balanced and supportive work environment.
• 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
Feasibility, Start-Up & Activation Support (70%)
• 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

Quality Assurance (20%)
• 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

Regulatory Documentation & Systems Maintenance (10%)
• 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

EDUCATION
• Required: Bachelor’s degree
• Preferred: Master’s degree

WORK EXPERIENCE
• 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

LICENSES AND CERTIFICATIONS
• Preferred: CCRP-Certified Clinical Research Professional, CCRC-Certified Clinical Research Coordinator, CHRC-Certified in Healthcare Research Compliance

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.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

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