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 quality checking of RA documents from local study teams and sites.
• Assist in preparing study submission packages (Initial Submissions, Amendments) for Ethics and Regulatory Bodies.
• Manage RASSU SharePoint, resourcing trackers, and Business Intelligence (BI) report tracking.
• Maintain study documentation in the study start-up module and electronic Trial Master File (eTMF).
• Arrange and track shipments of regulatory documents and packages.
• Provide administrative support to team members, including preparing meeting agendas and minutes.

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.