Memorial Sloan Kettering is currently seeking a Clinical Research Monitor 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 on-going portfolio of MSK IITs requiring Monitoring. Monitoring assignments will include but not be limited to: protocol compliance, data verification and GCP/ICH requirement, in real-time.
Ensure study conduct is in accordance with the CR protocol and applicable policies and regulations. Provide monitoring visit findings in standard format.
Work closely with PI and Study Team throughout the monitoring process as needed. Guide and direct PI/Study Team as appropriate, when there are significant concerns or issues identified.
Provide real-time education and support to the PI/Study Team, when needed.
Meet with PIs and Study Teams to review monitoring findings and the development of Corrective Action Plan, if required.
Participate in and conduct real-time eligibility verification, as per defined schedule and in accordance with established standards and policies.
Track verification findings and summarizes for QA Leadership.
Work with CR IT and CTMS Team on any eligibility/system concerns that arise.
5 years of relevant experience, specifically in a Quality Assurance (Audit/Monitor) space
Human Subjects Protection Certification, GCP Certification, GMP Knowledge, FDA/EMA requirements, Quality Standards and Systems experience.
Federal Regulations: Must have an advanced comprehensive 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).
This position will be primarily remote but there may be occasional in-person meetings in NYC.
Applications can be sent to: https://externaltalent-mskcc.icims.com/jobs/57398/clinical-research-monitor/job?mode=view
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
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.