Clinical Trials Safety Specialist

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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.

MD Anderson Cancer Center is a leading institution focused on cancer care, research, education, and prevention. The Clinical Trial Safety Specialist contributes in 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.

Minimum $42.31 - Midpoint $52.88 - Maximum $63.46

Location: Texas Medical Center

Schedule- Hybrid; onsite at least twice a month and additional based on business needs.

Why Us?

This role directly supports MD Anderson's mission by safeguarding participant safety and strengthening the quality of clinical research. The position offers opportunities to deepen expertise in safety monitoring, data analysis, and protocol oversight while working within a collaborative environment that values professional development and work-life balance.

• 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 & 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 report data to determine whether protocol stopping boundaries have been met
• Provide guidance to research teams on dose escalation, de-escalation, and dose expansion based on protocol design
• Identify, track, and analyze adverse events, near misses, and patient safety incidents to detect trends and support process improvements
  
  

Communication & Education

• Deliver study-specific safety training to investigators and study personnel prior to study activation, including safety reporting and protocol stopping boundary monitoring
• Assist research teams with safety-related questions
• Provide research teams with educational resources related to safety requirements
  
  

Protocol Review

• Review new protocols to ensure that safety language aligns with current departmental standards
• Develop safety and efficacy stopping rules and monitoring plans for new studies
• Review study modifications for changes that affect safety language or require updates to stopping boundary monitoring plans
  
  

Quality Assurance

• Ensure work is performed in accordance with departmental standard operating procedures
• Apply critical thinking to identify and escalate safety concerns to senior staff or management
• Maintain institutional compliance with federally mandated safety monitoring and reporting requirements through current clinical and research knowledge and ongoing education
  
  

Other Duties

• Perform other duties as assigned
  
  

EDUCATION

Required: Bachelor's degree in a nursing, health science, or related field

Preferred: Master's degree or other advanced degree in medicine or health science

Experience

Required: Four years of clinical experience to include two years of clinical research.

Preferred: Five years of clinical experience to include two years of clinical research with one-year clinical trial safety reporting experience. Precious research management experience is preferred.

CERTIFICATION

Required: None

Preferred: Current license to practice professional nursing (RN), Advanced Oncology Certified Nurse (AOCN), Oncology Certified Nurse (OCN), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA), Regulatory Affairs Professional (RAP), or similar.

The University of Texas MD Anderson Cancer Center offers excellent https://www.utsystem.edu/offices/employee-benefits/ut-retirement-program/voluntary-retirement-programs, 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: 178929
• 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
  
  

If you have questions about this posting, please contact [email protected]