Clinical Trials Quality Specialist

Responsibilities
The Quality Specialist, in collaboration with the Juravinski Cancer Centre (JCC) Clinical Trials Department (CTD) Clinical Manager, Medical Head, Program Director, and other internal Stakeholders, shall be responsible for executing a comprehensive Quality Management System (QMS) that includes

• Quality Control to detect defects - processes, policies and procedures that ensure that product quality is as per the set standards, and
• Quality Improvement to improve performance, reduce defects and variation - processes for the continuously increasing the quality standards and performance.
• Quality Assurance to protect from defects - processes, policies and procedures which guarantee that the preferred level of quality is fulfilled in the product or service at each phase of the process;

The incumbent works on problems of a diverse scope where analysis of data requires evaluation of identifiable factors. Applies knowledge of research regulations and guidelines and continuous quality improvement to evolve operational efficiencies and standardize processes to improve protocol compliance, data integrity, and patient safety. The Quality Specialist identifies risks to the CTD management team and advises on corrective and preventative actions. Works with minimal supervision.
Bachelor’s degree in health related field or equivalent; Master’s in Healthcare Quality considered an asset

• Experience with data collection, monitoring, audits, and CAPA plans
• Demonstrated ability to prioritize workload and perform multiple concurrent tasks
• A high degree of motivation and self-directedness
• Systematic thinker with strong project management and organizational skills
• Mastery of Excel spreadsheet functionality and other software applications, e.g., Power BI
• Demonstrated ability to express complex technical concepts effectively
• Minimum five (5) years clinical research experience in a health care setting
• Experience with modifying, implementing, validating, and maintaining a web-based Clinical Trials Management System, including trouble shooting operational problems
• Experience with, or certification in Lean or Six Sigma considered an asset
• Strong interdisciplinary and team building skills
• Minimum three (3) years cancer related experience
• Familiarity with drug development process and phases of clinical research
• Strong technical writing skills (procedures, protocols, and reports)
• Exceptional external stakeholder and cross-departmental customer relations
• Experience teaching and mentoring adults
• Minimum three (3) years practical experience developing and implementing quality management systems to enhance operational processes, work flow, and performance, and improve communication and knowledge transfer
• Functional experience in clinical research ethics and processes involved in study conduct
• Effective verbal and written communication skills
• Recognized certification in clinical research (ACRP or SOCRA) preferred
• Ability to interpret and apply general regulatory requirements to specific operational situations
• Strong analytical skills with particular attention to detail
• Ability to design, manage, and lead quality improvement initiatives
• Graduate certificate in clinical research from an accredited university or college
• Demonstrated knowledge of applicable research regulations, guidelines, and HHS and departmental policies

As a condition of employment, you are required to submit proof of full COVID-19 vaccination to Employee Health Services.
Job
Administrative/Service
Primary Location
Ontario-Hamilton
This position will be located at
Juravinski Cancer Centre
Organization
Research
Status
Regular
Hours per week
37.5
Number of Openings
1
Union Code
Non Union Employees
Minimum Salary
41.3000
Maximum Salary
52.9500
Post Date
May 8, 2023, 11:00:00 PM
May 15, 2023, 10:59:00 PM
Unit Summary
The Juravinski Cancer Centre (JCC) is a comprehensive tertiary centre for cancer care and cancer research and a leader in cancer clinical trials. Operated by Hamilton Health Sciences (HHS), it is adjacent to the Juravinski Hospital (JH), a full-service general hospital that helps to support a broad range of cancer programs from prevention, screening, and diagnosis to treatment. The JCC Clinical Trials Department (CTD) is a large centralized team of dedicated research professionals responsible for the overall management and coordination of several studies across all disease sites and treatment modalities. We are looking for individuals interested in being part of a research intensive cancer program dedicated to learning, finding answers, and delivering on HHS' vision of providing "Best Care for All" to patients living with cancer. HHS is an affiliate institution of McMaster University in Hamilton.
Schedule Work Hours
Monday to Friday; days
Guidelines
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 905-521-2100, Ext. 46947for 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 13.01 (b) (ii), OPSEU 273 Collective Agreement
Article 14.04, OPSEU 209 Collective Agreement
Article 2.07 and Article 13, PIPSC RT Collective Agreement