Clinical Project Associate

Il y a 5 jours

Machelen, Vlaams-Brabant, Belgique Jobtailor Temps plein 45 000 € - 60 000 € Contrat

Responsibilities

  • Perform activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
  • Assist 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
  • Create and assist with maintenance of Trial Master File (TMF) and project files, including participation in file audits
  • Prepare and maintain site manuals, reference tools and other documents
  • Maintain, update, and input clinical tracking information into databases
  • Track incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
  • Manage shared mailbox, process site requests and route correspondence appropriately
  • Coordinate the ordering, packaging, shipping and tracking of site supplies and materials
  • Assist with coordination of team meetings, attend meetings and prepare accurate meeting minutes and action items
  • May handle receipt, tracking and disposition of Case Report Forms and Queries
  • Maintain 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