Training & Compliance Coordinator

The Training & Compliance Coordinator supports the relevant manager to drive a culture of compliance and quality within Clinical Research. The objective of this role is to support the development of policies and procedures; coordinate training initiatives; and act as a resource to coordinate, oversee or support other quality initiatives, including audits, inspections and CAPA development. This role will also support effective communication within and across departments. Responsibilities may also include laboratory assay quality control (QC) for partner laboratories.

Audits & Inspections

•  Support audits, inspections, and QA investigations by collecting and/or organizing documents and other items.
• Records minutes at internal inspection meetings; tracks action items; coordinates timely follow-up.
• Performs reviews and cross-checks of study documentation to ensure inspection readiness

Metrics & KPI's

• Support CAPA and issue management and resolution; tracks issue resolution and coordinates timely follow-up and documentation; supports the writing of CAPAs as needed
• Support relevant metrics initiatives by updating or reviewing source data; creating and distributing metrics reports; flagging potential process improvement opportunities.
• Supports lessons learned processes, as applicable.

Quality System Documents

•  Provide input on SOPs and Work Instructions (WIs). •
• Develop, or support the development of, tools and templates to support the implementation of SOPs and WI.
• Work with other departments on cross functional quality focused initiatives

Training

• Review training compliance and highlight pending trainings.
• Coordinate training curriculum, including on-boarding if relevant
• Support the development and/or revision of training materials.
• Support communications initiatives within the department to ensure a common understanding of compliance and/or training related issues.

Qualifications

• The successful candidate should possess at minimum, a college diploma or certificate with 1-3 years of related experience and on the go training. Educational background in life sciences/clinical research is preferred. Strong attention to detail, quality-focus and organizational skills. Proficient in use of relevant software platforms or able to learn. Proficient in use of Microsoft Office applications. Knowledge of Good Clinical Practice (GCP) is preferred, and knowledge of data management processes is considered an asset.