The Training & Compliance Specialist (TCS) drives a culture of compliance within Clinical Research. This role evaluates the quality status of project deliverables by reviewing applicable project quality metrics and/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 TCS determines appropriate mitigation measures. This role also leads 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.
\n- 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.
- 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.
- 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.
- Work with project or functional teams to monitor lessons learned.
- Ensures any gaps highlighted through learnings are appropriately addressed through training or process development.
- 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.
- 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.
- The successful candidate should hold either an undergrad degree with 4-6 years of relevant experience, or a college diploma with 7-9 years of relevant experience.
- Health Sciences, Sciences or Clinical Research specialty preferred.
- Excellent interpersonal, verbal and written communication skills.
- Customer focused approach to work.
- A flexible attitude with respect to work assignments and new learning.
- Ability to manage and prioritize tasks efficiently and accurately.
- Ability to work in a matrix environment and to value the importance of teamwork.
- Ability to analyze and interpret data.
- Attention to detail and organizational skills.
- Ability to work independently and take ownership of and responsibility for work assigned.
- IT literate. Experience with Microsoft based applications and a general knowledge of PC functions.
- Culturally aware and ability to think and work globally.
