Training and Compliance Specialist

JOB LOCATION: Canada

JOB SALARY: $64,000 - $107,000 + Bonus

JOB TITLE: Training and Compliance Specialist

JOB REPORTS TO: Manager, Clinical Operations Quality, Training & Compliance

DEPARTMENT/UNIT NAME:  Clinical Operations

JOB SUMMARY:

The Quality, Training and & Compliance (QTC) Specialist drives a culture of compliance within Clinical Research. This role evaluates the quality status of project deliverables by reviewing applicable project quality metrics and/or documentation and identifies and evaluates potential risks and quality issues in collaboration with project team leadership and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, the QTC Specialist determines appropriate mitigation measures. This role will also lead the development of relevant policies and procedures; leads training initiatives; acts as a resource for audits and inspections; and supports or manages the CAPA process. Responsibilities may also include laboratory assay quality control (QC) for the histopathology laboratory.

ROLE & RESPONSIBILITIES:

Audits and Inspections

• Lead audit/inspection readiness activities including conducting routine/periodic quality assurance assessments to measure and ensure adherence of departmental processes and procedures by internal personnel and external vendors.
• Support conduct of inspections and audits and closely collaborate with Global QA department in preparation of internal audits and regulatory inspections including preparation, review and provision of relevant documents, assigning roles and responsibilities for each audit/inspection.
• Analyze audit and inspection findings and suggest remediation as well as maintain overview of CAPA responses and resulting measures.

CAPA Resoultion

• Drive and manage an effective corrective action and preventive actions (CAPA) process including but not limited to the tracking, trend analysis, root cause analysis and implementation of process improvement measures.

Project Metrics and Key Performance Indicators (KPIs)

• Implement and update standardized metrics (including but not limited to issue resolution time, start-up timelines, set up timelines for project activities and tools etc) and other KPIs.
• Work with study teams to implement tracking of desired metrics and KPIs.
• Monitor metrics across studies, provide trend reports, and work with relevant partners to identify potential areas for process improvements.

Quality System Documents

• Lead the scheduled review of WIs and SOPs.
• Lead the development of new SOPs and WIs as required.
• Support identification of gaps in current procedures and support assigned team members in writing or adapting WIs and SOPs.
• Develop, or oversee development of templates and tools to support the implementation of SOPs and WIs.

Training

• Review training compliance, highlight pending trainings, and support completion/file forms 239
• Proactively work to identify unmet training needs.
• Support creation of a departmental training curriculum.
• Lead the creation of training materials and training implementation.
• Lead communication efforts to ensure a common understanding around processes.

Laboratory Assay QC (if applicable)

• Perform and/or oversee the performance of random QC on assays performed at the laboratory
• Shadow laboratory technicians at the laboratory to assess quality of the work and adherence to SOPs and regulations.

QUALIFICATIONS:

Job Experience & Education Requirements:

• Undergraduate university degree (Bachelor or Honors Bachelor) and 4-6 years related experience +substantial on-going job-related training

OR

• College Diploma/Degree and 7-9 years related experience +continuous training and knowledge/skills upgrading
   

WORKING CONDITIONS:

 Home-based

*Accommodations for job applicants with disabilities are available upon request


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