Research Data Associate

NYU Grossman School of Medicine • New York, NY • 2h ago

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram.Position Summary:We have an exciting opportunity to join our team as a Research Data Associate. In this role, the successful candidate is responsible for the coordination of basic level cancer clinical research studies conducted at the Laura and Isaac Perlmutter Cancer Center. Performs enrollment and data entry. Interfaces directly with Principal Investigators, clinical study team members, regulatory specialists, quality assurance specialists, financial coordinators, study monitors, and service rendering departments as needed in support of the cancer clinical trials. Works under general supervision.Job Responsibilities: Demonstrates knowledge of the organization's Core Values and incorporates them into the performance of duties.Human Subjects Research: 1. Responsible for study data entry and query resolution on all assigned simple studies, ensuring data is entered within 1 week or less from the last study visit. 2. Logging study visits into the Clinical Research Management System (CRMS) as they occur to ensure study sponsors are billed for research procedures in a timely and efficient manner. 3. Requesting pathology reports and tissue acquisition required per the study protocol. 4. Coordinate the submission of imaging with the Department of Radiology. 5. Schedules monitoring visits as needed. Coordinates the visit with the study monitor, the CTO Administrative Assistant and Vornado Realty Trust. Requests charts and access to the Electronic Medical Record for study monitors and records all visits in the Data Coordination Unit (DCU) SharePoint. Communicates the change of a monitor, or additional monitors on site to the Business Operations Unit (BOU) for billing purposes. 6. Perform vial assignments and communicates with the study team and investigational pharmacy in a timely and efficient manner. Assists with eligibility review and subject registration with study sponsors, and within the CRMS system. 7. Coordinates the submission of Serious Adverse Events (SAEs) and other reportable events to the Data and Safety Monitoring Committee when applicable, the study sponsor, and the Institutional Review Board (IRB). Regulatory: Develops a working understanding of Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research. * Research Activities - Collects patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.); abstraction of data for publications, or data collection from outside physicians offices. Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc.). Updates the database or the case report forms. Assists in reviewing medical history and screening procedures to confirm patient eligibility on protocol. Reports all adverse events and serious adverse events to applicable agencies. Attends resea

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