Company Overview

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.

Job Description

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 Monitor/Monitor to join our growing team. Join us today and help make a difference every day!

You will:

• 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).

You need:

• At least 2 years of clinical research experience for Clinical Research Associate Monitor position; at least 3 years clinical research experience for Clinical Research Monitor position.
• At least one year of direct QA experience (CRM only).
• Human Subjects Protection and GCP Certifications.
• Knowledge of FDA/EMA requirements; Quality Standards and Systems experience (CRM only).
• Advanced comprehensive knowledge and understanding of the federal regulations pertaining to human research protection and the Health Insurance Portability and Accountability Act (CRM only).

This position will be primarily remote but there may be occasional in-person meetings 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!

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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.