Memorial Sloan Kettering is seeking Clinical Research Auditors to join our growing Clinical Research Quality Assurance team.
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. We’re treating cancer, one patient at a time. Join us today!
· Conduct all types of audits (protocol compliance, CR database systems, etc), as determined by QA Leadership.
· Complete audits based on experience and a comprehensive understanding of all federal regulatory requirements and ICH guidance on Good Clinical Practice.
· Perform required number of audits each month, supporting team members with audits as needed.
· Work with QA Leadership to provide feedback, deficiencies and common trends identified in audits to ensure timely and effective change control to improve overall quality.
· Collaborate with Principal Investigators and Research Teams on addressing audit findings and developing corrective action and preventive action plans.
· Serve as the Clinical Research Quality Assurance liaison between external auditors/inspectors and MSK PIs/Research Teams during external audits and inspections, serving as the subject matter expert on federal regulations, ICH GCP and institutional policies.
· At least 5 years of clinical research experience.
· Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
· Federal Regulations: Must have advanced comprehensive knowledge and understanding of the regulations pertaining to human research protection (including 21 CFR and 45 CFR 46 of the US Code of Federal Regulations) and the Health Insurance Portability and Accountability Act.
This position will be primarily remote but there may be occasional in-person meetings in NYC.
Competitive compensation packages | Sick Time | Generous Vacation+ 12 holidays to recharge & refuel | Internal Career Mobility & Performance Consulting | Medical, Dental, Vision, FSA & Dependent Care | 403b Retirement Savings Plan Match | Tuition Reimbursement | Parental Leave & Adoption Assistance | Commuter Spending Account | Fitness Discounts &Wellness Program | Resource Networks | Life Insurance & Disability | Remote Flexibility
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It’s important to us that you have a sense of impact, community, and work/life balance to be and feel your best.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.