Clinical Research Monitor
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.
We are seeking a Clinical Research Monitor to join our Clinical Research Quality Assurance team.
Conduct on-going portfolio of MSK IITs requiring Monitoring, as directed by Senior CR Monitor and Manager, CR Monitoring. Monitoring assignments will include but not be limited to: protocol compliance, data verification and GCP/ICH requirement, in real-time
Follow monitoring guidelines for each protocol reviewed.
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.
Record and provide monitoring results in real-time to QA Leadership
Participate in and conducts real-time eligibility verification, as per defined schedule.
Ensure timely completion of eligibility verification 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.
Support QA Leadership in drafting summary quarterly reports, discussing potential workflow improvements or solutions, evaluating verification procedures, etc.
- Assist in Oversight of Monitoring and Auditing Tracking System (MATS)
- Data Reporting, Quality Management, Operations
- Adept at planning and prioritizing work to meet commitments aligned with organizational goals.
- A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
- An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.
- Bachelor’s degree with at least 5 years of clinical research experience (preferred), or a high school diploma with 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). #LI-POS
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.
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