Note this position is posted at WCM under the following title and requisition number: Human Research Compliance & Reliance Administrator (41382)
Assists in the implementation and day-to day regulatory operations of single IRB and reliance agreement process (IRB reliance requests, local context review of applicable IRB submissions, interactions with research community, etc.) and planning and execution of research compliance audits in support of the Weill Cornell Medicine (WCM) IRB Office and Human Research Protection Program (HRPP).
Reviews and manages IRB reliance requests under the guidance of the Assistant Director of Regulatory Compliance.
Exercises independent judgement in review and management of IRB Reliance Agreements and Independent Investigator Agreements, including the review of newly proposed agreements and associated documentation when determining reliance.
Coordinates with the Assistant Director of Regulatory Compliance to ensure that proposed reliances and the terms of agreements are acceptable to the WCM IRB.
Facilitates the reliance process by serving as liaison between WCM, external organizations and IRBs, and researchers regarding matters related to IRB reliance.
Facilitates and/or conducts local context review of applicable IRB submissions, including regulatory pre-reviews of human research studies to ensure regulatory and institutional compliance; works closely with IRB members to address local context concerns.
Ensures that the WCM IRB database contains up-to-date and accurate information regarding external IRB reliance studies for reporting, quality, and oversight purposes.
Assists researchers, IRB members, staff, and others on the IRB reliance process.
Develops materials and processes to support researchers, IRB members, and staff compliance with the terms of reliance agreements.
Responsible for planning and conducting for-cause audits to ensure adherence to local and federal requirements.
Drafts audit reports providing comprehensive evaluation of audit findings, including both proposing and assessing corrective and preventative action plans, conducting trend analysis and making training proposals to investigators.
Assists with developing metrics/reports to monitor strategic goals & initiatives for functional areas of: Data and Safety Monitoring Committee (DSMC), for-cause audit, Clinicaltrials.gov compliance, and Embryonic Stem Cell Research Oversight (ESCRO).
Assists with compliance training initiatives, including coordinating educational sessions, writing and editing compliance manuals and developing presentations.
Serves on internal subcommittees, e.g. policy subcommittee, process improvement, etc. to assist with building the WCM HRPP.
Maintains a current and working knowledge of federal, state and local regulations and institutional policy and procedures to ensure the WCM IRBs and HRPP are in compliance with applicable mandates.
Performs other related duties as directed.
At least 5 years of progressive experience in quality assurance, IRB operations or sIRB/Reliance processes.
Extensive knowledge of and proven experience with implementing federal and industry regulations that govern human subject research protections.
Experience with, or direct knowledge of, several quality system elements (e.g. document management, complaint investigation, CAPA, risk-based monitoring) is preferred.
Advanced knowledge of Microsoft Office Suite, REDCap, Adobe is highly desired.
Knowledge, Skills and Abilities
Excellent communication skills (both verbal and written).
Strong problem solving and decision making skills and the ability to make decisions independently.
Ability to take initiative and simultaneously manage multiple projects with minimal supervision.
Highly organized and able to prioritize and handle multiple tasks simultaneously
Internal Number: 41382
About Weill Cornell Medicine
Weill Cornell Medicine is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. Since 1898, our doctors and scientists have been engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies.