We are seeking a Clinical Research Audit Specialist to join our Clinical Research Audit Team . You will help ensure that clinical research programs at MSK adhere to all federal regulatory requirements and ICH guidance on Good Clinical Practice.
Actively participate in and support the daily operations of MSKs centralized clinical research audit program.
Conduct all types of audits (protocol compliance, CR financial, CR database systems).
Perform a required number of audits each quarter, supporting team members with audits as needed.
Support data management needs of the CR Audit Team including but not limited to Audit Metrics, Operational Reports and analytics.
Report to a Senior CR Auditor.
Bachelors degree with at least 3 years of clinical research experience
Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience preferred
Excellent oral and written communication skills
Knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA) preferred
Internal Number: 2021-51496
About Memorial Sloan Kettering Cancer Center
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.