Clinical Trial Activation Specialist
About The Position
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. The Clinical Trial Activation Specialist oversees the clinical trial activation process at MD Anderson. Acts as a liaison between different central departments and research teams throughout the lifecycles of the clinical study. Maintains real-time tracking of the progress and milestones of assigned trials and proactively alerts to potential delays. Responsible for confirming all institutional requirements are met prior to activation/implementation. The ideal candidate will have prior experience in regulatory compliance or clinical research start-up. This role allows the Clinical Trial Activation Specialist to directly contribute to accelerating clinical studies that improve outcomes for patients with cancer, while benefiting from a remote work arrangement that supports work-life balance and long-term professional growth.
Requirements
- Bachelor’s Degree
- Four years in regulatory compliance or clinical research start-up
- May substitute education degree with additional years of experience on a one to one basis
- CCRP – Certified Clinical Research Professional or CCRC – Certified Clinical Research Coordinator or CCRA – Certified Clinical Research Associate
Nice To Haves
- Master’s Degree
Responsibilities
- Responsible for the facilitation of protocol acceptance, activation, and modification implementation for clinical research protocols.
- Facilitate protocol acceptance, activation, and modification implementation for clinical research studies.
- Oversee effective operation of protocols involving collaboration with clinical research administration, departments, and central offices.
- Serve as the primary resource for maintaining study status information across assigned trials.
- Document delays in activation and identify bottlenecks in activation and implementation processes.
- Manage new study submission and activation after confirming all institutional requirements are met.
- Develop and maintain a tracking system to monitor protocol activations and modifications.
- Maintain up-to-date status updates between central offices, research staff, and departments throughout the study life cycle.
- Navigate protocols through clinical research systems by coordinating with multiple stakeholders.
- Prepare for and attend clinical department meetings for assigned departments.
- Serve as a content expert to guide departments through the activation process.
- Assure appropriate written regulatory documentation and standard operating procedures are maintained.
- Maintain up-to-date knowledge of institutional policies, databases, and systems used in clinical trial workflows.
- Utilize systems such as CTMS, the IRB system, and other indicated research platforms.
- Perform other duties as assigned to support clinical research at UT MD Anderson.
Benefits
- Employer-paid medical coverage starting day one for employees working 30+ hours/week
- Optional group dental, vision, life, AD&D, and disability insurance
- Accruals for PTO and Extended Illness Bank
- Paid holidays
- Wellness, childcare, and other leave options
- Tuition Assistance Program after six months of service
- Access to extensive wellness, fitness, and employee resource groups
- Defined-benefit pension through the Teachers Retirement System
- Voluntary retirement plans
- Employer-paid life and reduced salary protection programs
- medical
- dental
- paid time off
- retirement
- tuition benefits
- educational opportunities
- individual and team recognition
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
