19 mei 2026
Clinical Study Assistant (TEMP)
| Branche | Zie onder |
| Dienstverband | Zie onder |
| Uren | Zie onder |
| Locatie | Utrecht |
| Opleidingsniveau | MBO |
| Contactpersoon |
Olawale Olukunga +31622258890 |
Informatie
The Clinical Study Assistant is responsible for operational and administrative support throughout the clinical study within the global clinical research team. The Clinical Study Assistant is a member of the wider team, including Study Managers, Study Researchers, Data Managers, and the Supplies team.
Key tasks
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the applicable GCP guidelines and standard operating procedures;
- Prepare ISF (investigator site file) and TMF (trial master file) for the initiation of participating centers in clinical studies;
- Support the team with the financial management of the clinical studies;
- Support the team in contract management and vendor creation;
- Support the preparation and organization of internal and/or external meetings;
- Participate in the optimization of processes within the department;
- Act as a central contact for the clinical team for project communication, correspondence, and documentation;
- Support the team with any ad-hoc requests that come in internally and externally during execution of the study.
Omschrijving
The Clinical Study Assistant is responsible for operational and administrative support throughout the clinical study within the global clinical research team. The Clinical Study Assistant is a member of the wider team, including Study Managers, Study Researchers, Data Managers, and the Supplies team.
Key tasks
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the applicable GCP guidelines and standard operating procedures;
- Prepare ISF (investigator site file) and TMF (trial master file) for the initiation of participating centers in clinical studies;
- Support the team with the financial management of the clinical studies;
- Support the team in contract management and vendor creation;
- Support the preparation and organization of internal and/or external meetings;
- Participate in the optimization of processes within the department;
- Act as a central contact for the clinical team for project communication, correspondence, and documentation;
- Support the team with any ad-hoc requests that come in internally and externally during execution of the study.
Functie eisen
- Completed medical, pharmaceutical, life sciences, logistics, or administrative education at MBO level or higher (Bachelor's or Master).
- BSc / MSc: 1–2 years of relevant experience preferred but not mandatory.
- MBO: Minimum 5 years of relevant experience preferred;
- Knowledge of GCP is preferred
