Director Protocol Review & Monitoring System - Tisch Cancer Center

The Director for the Tisch Cancer Center’s Protocol Review and Monitoring System (PRMS) is responsible for ensuring that all cancer clinical research at Mount Sinai Health System (MSHS) receives appropriate feasibility and peer-review prior to activation and then regular monitoring for scientific progress. Reporting to the Senior Director for Cancer Clinical Research, this individual must be knowledgeable of the National Cancer Institute (NCI) guidelines related to cancer clinical trials and facilitate compliant documentation and capture of clinical trials data within our clinical trials management system (OnCore). This role supervises the PRMS Program Managers, who are responsible for study reviews by the Disease Focus Groups (DFGs) and the Protocol Review and Monitoring Committee (PRMC). The Director also supervises the Project Manager for the Finance and Feasibility Review (FFR) Committee.

• Serve as the main point of contact and subject matter expert for the PRMS of the Tisch Cancer Center (TCC) at MSHS.
• Provide timely instruction to faculty investigators and research staff on the PRMS processes.
• Demonstrate expertise in understanding federal and regulatory guidelines as it applies to clinical research at TCC.
• Research, interpret, and analyze cancer-related protocols and documents to ensure compliance with NCI requirements for a NCI-Designated Cancer Center.
• Supply guidance to PRMC members regarding the required levels of review, issues with protocol language, and adherence to the myriad rules and regulations designed to protect research science integrity.
• Supply guidance to various DFGs about required initial review from these groups.
• Oversee FFR processes and collaborate with key stakeholders on the FFR Committee to provide comprehensive and efficient review.
• Work in conjunction with internal departments to ensure regulatory and statutory requirements are implemented in pre-PRMS processes within mandated timeframes.
• Assist in development and standardization of Protocol Review Monitoring Standard Operating Practices across health system.
• Identify potential areas of improvement in committee functions. Progress and discuss corrective actions with the Senior Director for Cancer Clinical Research and applicable TCC leadership.
• Provide oversight for the organization and management of regular committee meetings whether via Zoom or in-person. Ensure complete meeting minutes are documented, saved, and distributed as needed.
• Create and maintain documentation of all PRMS activities and communications.
• Facilitate the annual scientific progress, accrual monitoring, and amendment review of all cancer-related studies.
• Create and maintain accurate and reliable data in the OnCore Clinical Trials Management System.
• Manage and guide the PRMS Program and Project Managers as needed in daily operations.
• Collaborate with TCC Clinical Research Leadership on reporting related to NCI Designation.

• Bachelors Degree required, Masters degree preferred
• 5-7 years minimum of experience in health care finance or administration; experience in strategic planning and execution, formulating policy, building and developing financial plans, managing resources and leading successful teams
• Experience in Clinical Research in cancer strongly preferred

Strength through Unity and Inclusion

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About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

Compensation

The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $140000 - $230000 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.