Clinical Trials Quality Specialist

The Quality Specialist, in collaboration with the Research Compliance and Support Services department (RCSS) and RCSS Manager, shall be responsible for executing a comprehensive Quality Management System (QMS) that includes:

a) Quality Systems, Risk Management, and Regulatory Compliance
b) Implement and Oversee Quality Management System
c) Continuous Quality Improvement
d) Research Personnel Support and Training

Applies knowledge of research regulations and guidelines and continuous quality improvement to evolve operational efficiencies and standardize processes to improve RCSS structure and support system, protocol compliance, data integrity, and patient safety. The Quality Specialist identifies risks to the RCSS management team and advises on corrective and preventative actions.

• Bachelor’s degree in health related field or equivalent; Master’s in Healthcare Quality considered an asset
• Minimum five (5) years clinical research experience in a health care setting
• Demonstrated knowledge of applicable research regulations, guidelines, and HHS and departmental policies
• Functional experience in clinical research ethics and processes involved in study conduct
• Ability to interpret and apply general regulatory requirements to specific operational situations
• Systematic thinker with strong project management and organizational skills
• Experience with data collection, monitoring, audits, and CAPA plans
• Demonstrated ability to express complex technical concepts effectively
• Strong interdisciplinary and team building skills
• Effective verbal and written communication skills
• Strong analytical skills with particular attention to detail
• Demonstrated ability to prioritize workload and perform multiple concurrent tasks
• A high degree of motivation and self-directedness
• Mastery of Excel spreadsheet functionality and other software applications
• Strong technical writing skills (procedures, protocols, and reports)
• Ability to design, manage, and lead quality improvement initiatives

Assets:

• Graduate certificate in clinical research from an accredited university or college
• Recognized certification in clinical research (ACRP or SOCRA) preferred