Clinical Trial Assistant

Job description

What you'll do As a Clinical Trial Assistant (CTA), you play a key role in ensuring clinical studies for medical devices and in vitro diagnostics (IVD) are executed in a controlled, structured, and compliant way. You are responsible for managing all trial-related documentation and data in accordance with ISO 14155 and Good Clinical Practice (GCP) guidelines. You are part of the Qserve CRO team and work with our clients’ teams and hospital staff. You ensure that all essential study documentation is complete, accurate, and audit-ready throughout the entire lifecycle of a clinical study. In addition, you will moderate for Qserve Insight, our regulatory intelligence platform. You will be the first one to review all the updates that will be coming through the platform. Distribute the work to our subject matter experts within the company. You will be involved in the administrative part of the platform managing customer subscriptions, free trials and internal Qserve users. Your CTA work will amount to app. 16-20 hours per week, whereas your Qserve Insight work will amount to app. 16-20 hours per week, assuming a 32- to 40-hour work week. In this role, you will: Gather, review, process, an...