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 and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
The Clinical Research Quality Assurance department at Memorial Sloan Kettering leads and carries out the overall design, implementation and maintenance of a robust, effective, and proactive monitoring/auditing program, while anticipating changes in regulations and best practices, to minimize the center's risk associated with its clinical research program.
We are currently seeking a Clinical Research Associate Auditor/Auditor (CRAA/CRA) to join our growing team. Join us today and help make a difference every day!
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.
Support data management needs of the CR Audit Program including, but not limited to Audit Metrics, Operational Reports and analytics.
Collaborate with Principal Investigators and Research Teams on addressing audit findings and developing corrective action and preventive action (CAPA) plans.
Serve as the Clinical Research Quality Assurance liaison between external auditors/inspectors and MSK PIs/Research Teams during external audits and inspections, and subject matter expert on federal regulations, ICH GCP and institutional policies (CRA only).
At least 2 years of clinical research experience for CRAA; at least 3 years clinical research experience for CRA.
At least one year of direct QA experience (CRA only).
Human Subjects Protection and GCP Certifications.
Knowledge of FDA/EMA requirements; Quality Standards and Systems experience (CRA only).
Advanced comprehensive knowledge and understanding of the federal regulations pertaining to human research protection and the Health Insurance Portability and Accountability Act (CRA only).
This position will be primarily remote with occasional in-person meetings required in New York City.
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. We want you 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.
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.