Clinical Research Associate - Trilingual
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.
We are currently looking for a Clinical Research Associate to manage relevant activities and related issues that may arise, i. e. :
- Taking the responsibility of monitoring activity for study investigative sites that have been assigned. This includes ensuring that all data collected by the site is consistent with the actual data filed and monitored on site, that technical and human resources are put in place and operational, that patients’ files are available and well documented, that information reported by the site is correct and true, that the site follows the GCPs.
- Efficiently manage the planning with the site in order to ensure an adequate rate of monitoring and/or sites contacts, as per applicable procedures and plans.
- Identify any issue or blocking point to the study running on the site.
- Ensure transparency in the escalation of information to the Project Team.
- Prior to communicate, ensuring that information is true and can be verified.
- Alerting the Monitoring Lead about any deviation or finding that may have a negative impact for the project
- Ensuring that Clinical Studies are performed in accordance with the GCPs, Pharmacovigilance requirements and applicable regulations.
- Participating to the development of Project dashboards for tracking and reporting related to monitor’s activities.
- Participating to the preparation of study documents and tools and proposing improvement ways (investigators lists, study logistics, data management activities, other…)
- Contributing proactively to the development of operational procedures in terms of Clinical Research and follow operational procedure wherever applicable.
- Experience as a CRA in a CRO, Pharmaceutical company or public environment
- Master's degree and/or Diploma of Clinical Research Associate
- Fluent in English. French and Dutch
- Computer Skills (MS Office, CRF tools…)
- Proven communication skills
- Team spirit and ability to escalate information on time, according to the level of importance.
- Solution-oriented mind-set
Does this sound exciting to you? If so, we look forward to meeting you!Apply