Regulatory Affairs Coordinator

Responsibilities

• Act as a liaison between NEXT Oncology, the Institutional Review Board (IRB), and pharmaceutical/biotech sponsors to facilitate clinical trial openings
• Draft and revise informed consent forms and submit new studies or protocol changes to the IRB
• Submit reportable events to the IRB, including serious adverse events, safety reports, and protocol deviations
• Ensure studies remain active by submitting continuing review reports and closure notifications on time
• Maintain study-specific information in internal databases to provide a complete history of each clinical trial
• Complete essential clinical study documentation such as Form FDA 1572s and Protocol Signature pages
• Coordinate with Research Coordinators to ensure patient-facing materials are available in all required languages
• Attend Phase I meetings, Site Initiation Visits, and other relevant clinical meetings

Requirements

• Bachelor's degree in administration or science
• 3+ years of experience in Regulatory Affairs within a research setting
• Proficiency in Microsoft Word and Adobe Acrobat
• Excellent verbal and written communication skills

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.