RASSU Coordinator

Responsibilities

• Provide administrative and regulatory assistance to the Regulatory Affairs Study Start-up (RASSU) Department
• Assist in the compilation and revision of Regulatory Affairs (RA) documents required for clinical trial submissions
• Support the collection and checking of RA documents from local study teams and sites
• Perform quality checks of documents within the study start-up module and the eTMF
• Assist in preparing study submission packages, including initial submissions and amendments, for Ethics and Regulatory Bodies
• Manage RASSU SharePoint, resourcing trackers, and Business Intelligence (BI) report tracking
• Arrange and track the shipment of regulatory documents and packages
• Maintain study documentation in electronic or paper TMF systems using proper naming conventions
• Provide general administrative support to RASSU team members and participate in relevant trainings

Requirements

• Bachelor’s Degree in nursing, pharmacy, or a health/natural science field
• 0–1 year of research or regulatory experience
• Sound knowledge of medical and pharmaceutical terminology
• Understanding of the drug development and clinical trial processes
• Proficiency in Microsoft tools for editing, reformatting, and finalizing regulatory documents
• Excellent verbal and written communication skills in English
• Strong organizational, interpersonal, and time management skills

About the Company

CTI Clinical Trial and Consulting Services is a global, full-service clinical contract research organization (CRO) focused on advancing treatments for chronically and critically ill patient populations. We assist clinical research throughout the entire lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations collaborating with pharmaceutical, biotechnology, and medical device firms.