You will be responsible:

• For GCP Auditing and Inspection Readiness
• Supporting inspection readiness training, conducting and coordinating mock BIMO inspections. Coordinate and participate in the BIMO sponsor inspection, and other regulatory agency sponsor inspections
• Independently planning, scheduling, and conducting audits to assure that clinical investigations comply with all applicable regulatory requirements such as ICH E6 (GCP) and GRAIL policies and procedures
• Conducting complex routine and for-cause clinical study sites and vendor audits, support process audits, and manage with minimum oversight
• Documenting audit observations; evaluates impact and makes recommendations for corrective actions. Evaluate responses to audit findings and ensure that appropriate corrective actions are completed
• Contributing to the development of audit procedures and processes. Keeps current on and interprets worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes
• Working with colleagues on cross-functional GxP audit plans as required
• For GCP Compliance
• Assessing compliance of GCP clinical trial sites and processes against ICH E6 (GCP) and applicable global regulations
• Maintaining GCP related clinical SOPs in compliance with all applicable regulatory requirements and to align with existing company policies
• Performing impact assessments for development and revised controlled procedures
• Conducting periodic SOP gap assessment and provides remediation based on findings
• Assisting with establishing and implementing monitoring plans for clinical studies