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 different teams to conduct many types of audits within Clinical Research. This role is mostly remote, but requires some onsite reporting in Manhattan between 2-10 days per year.
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 5+ years of clinical research experience
Human Subjects Protection Certification, GCP Certification preferred
Regulatory understanding of HIPAA and human research protection regulations
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.