Clinical Trials Coordinator

3 days ago

Copenhagen, Copenhagen, Denmark Qmed Consulting AS Full time
Job Description

We are seeking a highly skilled Clinical Trials Coordinator to join our team at Qmed Consulting A/S.

About the Role

This is an exciting opportunity for an experienced administrative professional to work in a dynamic environment and contribute to the success of our clinical trials. As a Clinical Trials Coordinator, you will be responsible for ensuring the smooth operation of clinical trials from start to finish, while maintaining compliance with regulatory requirements.

Main Responsibilities
  • Trial Setup and Maintenance: Assist in setting up and maintaining trial master files, investigator site files, and electronic filing systems.
  • Distribution and Tracking: Prepare and distribute essential clinical trial documentation, track and file documents, and ensure databases/tracking tools are set up and maintained throughout the trial.
  • Study Documents: Oversee the preparation, maintenance, and distribution of study documents, including protocols, investigator's brochures, functional plans, and case report forms.
  • Trial Supplies: Manage and maintain trial supplies, including medical devices, patient information sheets, patient diaries, lab kits, and medical equipment for sites.
  • Meetings and Submissions: Assist with the organization of investigator meetings and study team meetings, including generating and distributing minutes, and assist with ethics/regulatory submissions and track submissions and approvals for various studies.
Requirements
  • Education: University degree in health sciences, biology, pharmacy, nursing, or similar field.
  • Skills: Excellent prioritization skills, attention to detail, great communication skills, proactive, flexible, able to multi-task, solid IT skills, and ability to work independently as well as within a team.
  • Knowledge: Understanding of clinical trial processes and needs, including knowledge of ICH GCP and ISO 14155.
About Us

Qmed Consulting A/S is a full-service medical device contract research organization (CRO) providing strategic consulting services. We specialize in medical devices, with departments in clinical affairs, regulatory affairs, and quality management. Our driving force is commitment to paving the way for new medical devices and ideas to enter the market. We value an open, trust-based, and creative working environment, great team spirit, and high-quality mindset.

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