Clinical Research Quality Assurance Specialist II – Activation, Cancer Center

• Perform quality assurance and oversight of higher-complexity research protocols
• Develop and disseminate clinical research education in accordance with federal regulations, institutional policies, and protocol requirements
• Develop departmental policies, procedures, and guidelines
• Provide recommendations and direction to clinical research teams to ensure compliance
• Conduct meetings to disseminate quality assurance findings
• Work with teams to resolve clinical research non-compliance through root cause analysis and corrective and preventative action plans
• Coordinate day-to-day administrative activities of the program
• Support teams in achieving the program's goals

• Appropriate experience may be substituted for education on an equivalent basis
• Minimum Required
  
  Education:
  
  Bachelor's degree
• Minimum
  
  Required Experience:
  
  4 years
• Fundamental knowledge of FDA regulations, ICH GCP, institutional and departmental policies and procedures
• Data utilization, complex problem solving, critical thinking, resource management, and writing skills
• Ability to detect and translate speech or other communication
• May occasionally require the ability to distinguish colors and perceive relative distances between objects
• Ability to occasionally lift moderate weight materials
• Ability to stand or walk continuously
• Occasional exposure to dust, noise, temperature changes, or contact with water or other liquids

Demonstrates expertise in quality assurance and compliance within clinical research, with a strong foundation in FDA regulations and ICH GCP. Capable of developing educational materials and departmental policies while effectively managing resources and problem-solving.

• Quality Assurance Oversight
• FDA Regulations Knowledge
• ICH GCP Familiarity
• Clinical Research Education Development
• Root Cause Analysis

• Quality Assurance
• Clinical Research Protocols
• Data Utilization
• Complex Problem Solving
• Critical Thinking
• Resource Management
• Writing Skills
• Policy Development
• Corrective Action Plans
• Compliance Recommendations

• Communication Skills
• Team Collaboration
• Meeting Facilitation

• Federal Regulations
• Institutional Policies
• Departmental Procedures
• Clinical Research Compliance
• Administrative Coordination