Julissa Velez

Senior Data Coordinator @Hackensack Meridian Health

Prepares reports and assists with statistical analysis-Maintains regulatory binders in accordance with FDA guidelines-Assists research nurse in the preparation of all audits performed by various governing agencies, study monitors, and internal affairs-Assures timely submissions of research data, laboratory specimens, and query correspondences to all research affiliates and statistical centers-Obtains and maintains valid Dangerous Goods Shipping Certification-Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Contract Research Organizations, and employees of Hackensack University Medical Center-Obtains patient consent for minimal risk studies. Organizes and prepares for all study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits-Verifies that all patients have provided informed consent prior to entering study specific data. Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs-Records accurate data by completing paper or electronic CRFs-Resolves data queries accurately and within study specific timeframes-Maintain adequate inventory of research supplies necessary for research activities-Ensures supplies and kits are current and safely disposes of expired/closed supplies-Centrifuges human specimens per study specific laboratory manual guidelines. Processes and ships human specimens and biologic agents per protocol guidelines and Federal Regulations-Obtains and copies research related Curricula Vitae for Investigators.