Site Quality and Compliance Lead – Roles and Responsibilities
- Ensure clinical trials and clinical research activities comply with FDA regulations, ICH-GCP guidelines, company SOPs, and applicable regulatory requirements.
- Monitor quality and compliance activities across Phase I–IV clinical trials, Expanded Access Programs, registries, and survey trials.
- Support audit and inspection readiness by conducting quality reviews, identifying compliance gaps, and ensuring proper documentation.
- Identify, assess, and manage clinical operations non-compliance issues in collaboration with Quality Medicine and cross-functional teams.
- Support the development and implementation of Corrective and Preventive Action (CAPA) plans to address audit findings and quality issues.
- Develop, coordinate, and deliver training programs for Clinical Development Operations teams to improve compliance and performance.
- Analyze quality metrics, identify trends, assess potential risks, and recommend appropriate risk mitigation strategies.
- Collaborate with Clinical Operations, Quality Assurance, Legal, Medical, and Regulatory Affairs teams to implement quality improvement initiatives.
- Support internal audits, sponsor inspections, process improvement projects, and the resolution of quality findings.
- Coordinate onboarding and ongoing training initiatives to ensure employees understand regulatory requirements, company procedures, and compliance expectations.
- Prepare and communicate quality reports, lessons learned, and compliance updates to relevant stakeholders.
- Ensure all activities are performed in accordance with applicable regulations, company policies, ethical standards, and business requirements.
