Clinical Project Associate

Role Overview

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Requirements

• Master degree in biomedical sciences or related
• Strong interest in clinical research
• Good communication and interpersonal skills
• Fluency in Dutch, English and French
• Ability to embrace new technologies
• Ability to work from the office in the Machelen/Zaventem region on a regular basis

Benefits

• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program