Clinical Trials Quality Specialist

• 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

Hamilton Health Sciences in affiliation with McMaster University Faculty of Health Sciences is home to one of the most research intensive environments for medical research in Canada. Our research is conducted through a series of research institutes, research centres and research groups, as well as investigators who work independently.  We support more than 450 researchers and their research teams and foster the development of students and research fellows. Themes and programs range from basic laboratory tests to trials in worldwide populations, involving hundreds of thousands of participants.

Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.

To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website.

Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact HR Operations at , Ext for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.

This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note\: the circumstances around an employee's exit will be considered prior to an offer of employment

Proficiency in both Official Languages, French and English, is considered an asset

If this position is temporary, selection for this position will be as per the outlined Collective Agreements:

Article 30 (k), CUPE Collective Agreement

Article 10.7 (d), ONA Collective Agreement

Article b) (ii), OPSEU 273 Collective Agreement

Article 14.04, OPSEU 209 Collective Agreement

Article 2.07 and Article 13, PIPSC RT Collective Agreement

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.

Full-time hours (37.5 hours/week), Mon-Fri.