What are the responsibilities and job description for the Clinical Trial Activation Specialist position at UT MD Anderson?
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.
Salary Information: Minimum $37.26/hour - Midpoint $46.63/hour - Maximum $56.01/hour
Why Us?
UT MD Anderson offers the opportunity to support groundbreaking clinical research while working in a collaborative, mission-driven environment. 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.
Activations and Modifications Support (70%)
Responsible for the facilitation of protocol acceptance, activation, and modification implementation for clinical research protocols.
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
Additional Information
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.
Salary Information: Minimum $37.26/hour - Midpoint $46.63/hour - Maximum $56.01/hour
Why Us?
UT MD Anderson offers the opportunity to support groundbreaking clinical research while working in a collaborative, mission-driven environment. 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.
- 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.
Activations and Modifications Support (70%)
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.
- Required: Bachelor's Degree
- Preferred: Master's Degree
- Required: 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
- Required: CCRP - Certified Clinical Research Professional or CCRC - Certified Clinical Research Coordinator or CCRA - Certified Clinical Research Associate
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
Additional Information
- Requisition ID: 182144
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 77,500
- Midpoint Salary: US Dollar (USD) 97,000
- Maximum Salary : US Dollar (USD) 116,500
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
Salary : $37 - $56