The Clinical Trial Assistant (CTA) is an essential position within a clinical operations team at a pharmaceutical company, a Clinical Research Organization (CRO) or a Clinical Research Unit in a university hospital. The CTA is responsible for project-supporting clinical drug research and development tasks. You will work closely with CRAs, (Clinical Research Associates), who monitor the progress of the study, as well as Clinical Project Managers. You will be responsible for maintaining the complete documentation for the studies assigned to you with the aim of ensuring complete and correct study administration in accordance with the SOPs (Standard Operating Procedures), as well as the ICH-GCP guidelines. You will have an important task in study start-up, (digital) sending, tracing and administration as well as saving of essential documents (e.g. CRFs, CVs, study protocols, investigator brochures, informed consent forms and study supplies such as study medication and laboratory supplies ). You will have a critical role in the filing of side effects. You will work together with research nurses and occasionally with researchers and physicians (investigators) in hospitals where respective clinical trials are being conducted. The CTA position holds different responsibilities related to personal growth or not. If you want to grow to CRA, for example, then you should have a completed HBO or Master’s background.
Some tasks / responsibilities of a CTA:
- Collecting, registering and archiving information and documents in accordance with the applicable GCP guidelines for clinical studies, both for local and international studies;
- Prepare ISF (investigator site file) and TMF (trial master file) for the initiation of participating centers in clinical studies;
- Identifying needs, bottlenecks and deviations within your own study team;
- Participate in projects or initiatives on request, or on your own initiative, or take on department-wide tasks to contribute to the optimization of processes within the department.
Your background and profile:
- In addition to prior education, a completed medical, pharmaceutical or administrative education at MBO level, or a higher level (Bachelor or Master) in Life Sciences;
- Excellent computer skills;
- Excellent organizational skills;
- Knowledge of medical termininology;
- Knowledge of GCP;
- Good communication skills in Dutch and English.
Terms of employment and salary
The starting salary of a Clinical Trial Assistant is between € 2.100,- and € 2.600,- per month, secondary employment conditions are competitive.
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