Clinical Trials Safety Specialist
- Requisition #: 180039
- Department: MultiCenter
- Location: Houston, TX
- Posted Date: 4/7/2026
The Division of Clinical Research provides high-quality, efficient infrastructure support for all aspects of clinical protocol research at MD Anderson. Through our offices, we are 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 Clinical Trial Safety Specialist is overall analysis of safety and efficacy data as required by protocol design. Work with Investigators, clinical research organizations and commercial supporters to streamline safety information reporting.
The ideal candidate for the Clinical Trial Safety Specialist will have study management experience such as serving as a research nurse or clinical research coordinator. The ideal candidate will also demonstrate proficiency with Microsoft Office products, specifically Word, Excel, and PowerPoint, and the ability to support safety monitoring activities within a clinical research environment
Minimum $42.31 - Midpoint $52.88 - Maximum $63.46 per hour
The typical work schedule includes a hybrid on-site requirement on the 1st and 3rd Wednesday each month from 10am-2pm.
Work Location: Texas Medical Center
Why Us?
This role offers the opportunity to directly support patient safety and the integrity of clinical research at one of the world's leading cancer centers. The position promotes professional growth through exposure to complex clinical trials, cross-functional collaboration, and ongoing education, while supporting work-life balance through a hybrid schedule.
• 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
Safety Data Review and Analysis
• Review safety and efficacy report data from MD Anderson-sponsored trials to ensure completeness and accuracy
• Report safety information to regulatory authorities in accordance with applicable regulations
• Analyze toxicity and efficacy data to determine whether protocol stopping boundaries have been met
• Provide guidance on dose escalation, de-escalation, and dose expansion based on protocol design
• Identify, track, and analyze adverse events, near misses, and patient safety incidents
• Establish systems and processes to capture, report, and trend safety events for continuous improvement
Communication and Education
• Provide study-specific safety training to investigators and study personnel prior to study activation
• Support research teams with safety-related questions and issue resolution
• Provide resources to address safety-related educational needs
Protocol Review
• Review new protocols to ensure safety language aligns with current departmental standards
• Develop safety and efficacy stopping rules and monitoring plans for new studies
• Review study modifications affecting safety language or stopping boundary monitoring plans
Quality Assurance
• Ensure work aligns with current departmental standard operating procedures
• Apply critical thinking to identify and escalate safety concerns to senior staff or management
• Support institutional compliance with federally mandated safety monitoring and reporting requirements through ongoing education
Other Duties
• Perform other duties as assigned
EDUCATION
Required: Bachelor's Degree Nursing, health science, or related field.
Preferred: Master's Degree Medicine or health science.
WORK EXPERIENCE
Required: Four years Clinical experience to include two years of clinical research.
Preferred: Prior study management experience such as serving as a research nurse or clinical research coordinator and proficiency with Microsoft Office products, specifically Word, Excel, and PowerPoint
LICENSES AND CERTIFICATIONS
Preferred: RN - Registered Nurse - State Licensure Upon Hire or
Preferred: AOCN - Advanced Oncology Certified Nurse Upon Hire or
Preferred: OCN - Oncology Nurse Certification Upon Hire or
Preferred: CCRP - Certified Clinical Research Professional Upon Hire or
Preferred: CCRC - Certified Clinical Research Coordinator Upon Hire or
Preferred: Certified Clinical Research Associate Upon Hire or
Preferred: Regulatory Affairs Certifications (RAC)-RAPS Upon Hire
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
Additional Information
#LI-Hybrid
The primary purpose of the Clinical Trial Safety Specialist is overall analysis of safety and efficacy data as required by protocol design. Work with Investigators, clinical research organizations and commercial supporters to streamline safety information reporting.
The ideal candidate for the Clinical Trial Safety Specialist will have study management experience such as serving as a research nurse or clinical research coordinator. The ideal candidate will also demonstrate proficiency with Microsoft Office products, specifically Word, Excel, and PowerPoint, and the ability to support safety monitoring activities within a clinical research environment
Minimum $42.31 - Midpoint $52.88 - Maximum $63.46 per hour
The typical work schedule includes a hybrid on-site requirement on the 1st and 3rd Wednesday each month from 10am-2pm.
Work Location: Texas Medical Center
Why Us?
This role offers the opportunity to directly support patient safety and the integrity of clinical research at one of the world's leading cancer centers. The position promotes professional growth through exposure to complex clinical trials, cross-functional collaboration, and ongoing education, while supporting work-life balance through a hybrid schedule.
• 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
Safety Data Review and Analysis
• Review safety and efficacy report data from MD Anderson-sponsored trials to ensure completeness and accuracy
• Report safety information to regulatory authorities in accordance with applicable regulations
• Analyze toxicity and efficacy data to determine whether protocol stopping boundaries have been met
• Provide guidance on dose escalation, de-escalation, and dose expansion based on protocol design
• Identify, track, and analyze adverse events, near misses, and patient safety incidents
• Establish systems and processes to capture, report, and trend safety events for continuous improvement
Communication and Education
• Provide study-specific safety training to investigators and study personnel prior to study activation
• Support research teams with safety-related questions and issue resolution
• Provide resources to address safety-related educational needs
Protocol Review
• Review new protocols to ensure safety language aligns with current departmental standards
• Develop safety and efficacy stopping rules and monitoring plans for new studies
• Review study modifications affecting safety language or stopping boundary monitoring plans
Quality Assurance
• Ensure work aligns with current departmental standard operating procedures
• Apply critical thinking to identify and escalate safety concerns to senior staff or management
• Support institutional compliance with federally mandated safety monitoring and reporting requirements through ongoing education
Other Duties
• Perform other duties as assigned
EDUCATION
Required: Bachelor's Degree Nursing, health science, or related field.
Preferred: Master's Degree Medicine or health science.
WORK EXPERIENCE
Required: Four years Clinical experience to include two years of clinical research.
Preferred: Prior study management experience such as serving as a research nurse or clinical research coordinator and proficiency with Microsoft Office products, specifically Word, Excel, and PowerPoint
LICENSES AND CERTIFICATIONS
Preferred: RN - Registered Nurse - State Licensure Upon Hire or
Preferred: AOCN - Advanced Oncology Certified Nurse Upon Hire or
Preferred: OCN - Oncology Nurse Certification Upon Hire or
Preferred: CCRP - Certified Clinical Research Professional Upon Hire or
Preferred: CCRC - Certified Clinical Research Coordinator Upon Hire or
Preferred: Certified Clinical Research Associate Upon Hire or
Preferred: Regulatory Affairs Certifications (RAC)-RAPS Upon Hire
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
Additional Information
- Requisition ID: 180039
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 88,000
- Midpoint Salary: US Dollar (USD) 110,000
- Maximum Salary : US Dollar (USD) 132,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Hard
- Work Location: Hybrid Onsite/Remote
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
#LI-Hybrid
