What you'll do

The Clinical Trial Assistant (CTA) is responsible for all document management in relation to the execution of clinical studies in such a way that it is controlled, and compliant with ISO14155 and Good Clinical Practice (GCP) guidelines. The CTA ensures, in collaboration with the other functions within the CRO, the sponsor (external customer) and site staff (healthcare professionals in hospitals) that all relevant documentation and data pertaining to a clinical study are gathered, uploaded in databases, structured, and stored such that Investigator Site Files, Trial Master Files, and other required data sets are compliant with applicable guidelines. The CTA supports the submission of documentation to Ethics Committees and national regulatory authorities, plans trial-related meetings, takes minutes, manages the content of various operations trackers, and gathers, requests, checks, and processes various data. The CTA provides overall administrative support to the entire CRO team including keeping track and up to date of agendas, general e-mail inboxes, trackers, training files, meeting minutes, and databases.

What you’ll bring to the team

• Post-secondary vocational education (MBO level);
• Some experience in an administrative, supportive function;
• Fluent in English;
• GCP knowledge is a must, ISO14155 is a plus;
• Accurate, independent, pro-active team player with good communication skills.

Interested?

Getting excited about a career in the dynamic and innovating world of medical devices? Then please submit your resume and motivation!