Regulatory Affairs Assistant

A clinical research organization is seeking a Regulatory Affairs Assistant to join their growing team! This role is an on-site role in Westbury, NY, with an annual salary of $55,000-$65,000.Qualifications:Experience in managing Electronic Medical RecordsProficient in SharePoint and Microsoft Office SuiteBackground in regulatory affairs or pharmaceutical industry preferredBachelor's degree in health-related field preferredResponsibilities:Maintain patient research charts (digital and hard copy).Create new patient research charts (digital and hard copy).Prepare documentation for review by Sponsor/CRO during monitoring visits and quality checks.Complete uploads of patient scans to imaging platforms (Clario, Ambra, Caylx, QMS, URG) and answer associated queries.Request medical records when needed.Handle and pack investigational product and supplemental drug for delivery to treatment sites.Achieve understanding of schedule of assessments for each protocol.Handle outreach and scheduling for CRA/Principal Investigator calls with Sponsors/CROs and vendors.Maintain CRA calendar, provide a month-at-glance print-out to team, keep team apprised of scheduling conflicts.Manage off-site storage, package / box records by study, complete requisition forms.Maintain company SharePoint, upload updated protocols, informed consents, pharmacy manuals.Benefits:Medical/Dental/VisionCompany-matched 401(k)PTO

Created: 2025-02-09