Director Protocol Review & Monitoring System - Tisch Cancer Center
About The Position
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.
Requirements
- Bachelors Degree required
- 5-7 years minimum of experience in health care finance or administration
- Experience in strategic planning and execution
- Experience in formulating policy
- Experience in building and developing financial plans
- Experience in managing resources
- Experience in leading successful teams
Nice To Haves
- Masters degree preferred
- Experience in Clinical Research in cancer strongly preferred
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
