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
