Training & Compliance Specialist

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.
**Audits and Inspections**:
- Lead audit/inspection readiness activities including conducting routine/periodic quality assurance assessments to measure and ensure adher...