Career Center

The Clinical Research (CR) Auditor actively participates in and supports the daily operations of MSKs centralized Clinical Research Audit Program. You will work collaboratively with many teams to conduct many types of audits within clinical research.

• Able to set priorities among several tasks and meet established goals on multiple large-scale development projects
• Strategic in communication, decision-making, and analyzing situations to make recommendations and convey timely information
• Excited to tackle new challenges and determine areas of improvement
• Knowledgeable in GMP standards, FDA/EMA requirements, Quality Standards and Systems

• Execute audits with a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance on Good Clinical Practice (GCP).
• Work with QA Leadership to provide feedback in audits to ensure effective change control that improves overall quality
• Collaborate with Principal Investigators (PIs) and Research Teams to address audit findings and developing corrective action/preventive action (CAPA) plans
• Serve as the liaison and subject matter specialist between external auditors/inspectors and MSK teams during external audits and inspections

• A bachelors degree with at least 5 years of clinical research related experience
• Human Subjects Protection Certification, GCP Certification preferred
• Regulatory understanding of HIPAA and human research protection regulations
• Excellent communication skills