Clinical Trial Assistant

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, and archive essential study documents in line with GCP requirements.

• Analyse and moderate regulatory updates on the regulatory intelligence platform.

• Distribute the work to our subjects matter experts within the company and proactively follow up the execution of assigned tasks.

• Managing customers subscriptions, free trials and internal Qserve user accounts.

• Set up, maintain, and update Investigator Site Files (ISF) and Trial Master Files (TMF) in collaboration with the clinical team.

• Register and manage study data in various systems, databases, and operational trackers.

• Request, check, and edit study-related data to ensure completeness and accuracy.

• Support submissions to Ethics Committees and national regulatory authorities.

• Assist clinical teams in preparing for monitoring visits, including documentation, scheduling, and follow-up communication.

• Plan, coordinate, and support study and team meetings, including agenda management and minute-taking.

• Maintain and update general email inboxes, training files, trackers, and other administrative systems.

• Provide broad administrative and organizational support to the CRO team to ensure efficient trial execution.

What you'll bring to the team

You are highly organized and detail-oriented, with a strong sense of responsibility for quality and compliance. You are at the start of your career and motivated to build a solid foundation within clinical research, with the ambition to grow into more advanced roles over time. You enjoy supporting complex projects and thrive in a structured, fast-paced environment where collaboration is key.

We are looking for someone who:

• Has recently completed a university degree (WO level), preferably in a health-related field (biomedical science, biology, biomedical engineering, or similar).

• Is eager to gain hands-on experience and develop within the clinical research field and regulatory intelligence.

• Is fluent in English, both written and spoken. Fluent in Dutch is a plus.

• A basic understanding of Good Clinical Practice (GCP); familiarity with ISO 14155 is a plus. Both are not mandatory.

• Works accurately and is able to manage multiple tasks and priorities independently.

• Is proactive, curious, and takes ownership of their work and development, and is able to learn quickly.

• Communicates clearly and works effectively with different stakeholders.

• Is a strong team player who enjoys supporting others and contributing to shared goals.

• Is motivated to grow within the organization and explore future career opportunities beyond the CTA role.

• Experience with AI applications (ChatGPT, Copilot, Claude, Manus AI, Notebook LLM, etc.).