Clinical Project Assistant

Responsibilities

• Support Clinical Project Managers and Directors in managing clinical project activities throughout all phases of a project.
• Assist in the development of clinical project plans, manuals, presentations, and other essential project documentation.
• Prepare initial drafts of meeting agendas, minutes, internal reports, and external communications.
• Maintain tracking tools, clinical systems, and shared document repositories used for project management.
• Support the review and tracking of site prescreening, screening, enrollment activities, and subject status.
• Assist with the setup and maintenance of Trial Master Files (TMF) and support TMF reconciliation.
• Manage and maintain clinical system user account requests and track project milestones.
• Coordinate clinical project-related supplies and assist with drug management and shipments to sites.

Requirements

• Bachelor’s degree in allied health fields (such as nursing or pharmacy), natural science, or an equivalent combination of education and experience.
• 0-2 years of experience in a clinical research-related field.
• Basic knowledge of medical and pharmaceutical terminology.
• Awareness of ICH/Good Clinical Practice (GCP) guidelines and drug development processes.
• Proficiency in Microsoft Office Suite.
• Strong organizational, communication, 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.