Due to the expansion of our international projects, we are pro-actively looking for experienced CRA's in different locations in Europe.
- Do you have experience in on-site monitoring of clinical trials?
- Do you speak fluently English + another European language (depending on the local site location)?
- And are you quality and service minded?
Then don't hesitate to send your application to become part of our international team!
--> These projects can be as a Valesta employee or as a Freelancer.
The CRA is responsible for “on-site” quality control of clinical trials to ensure that a clinical trial is conducted, recorded and reported in accordance with the protocol, the principles of Good Clinical Practice (GCP) and the applicable regulatory requirements.
- Perform on-site monitoring visits according to the monitoring plan and following the Standard Operating procedures (SOPs) and ICH-GCP guidelines
- Ensure and control sites’ compliance with study protocol/ regulatory obligations and check data quality
- Address issues in a manner that is beneficial for the site and the clinical team
- Respond to site-related queries and escalate site-related issues
- Report the findings of the “on-site” monitoring visits (f.e. SAE reporting)
- Follow the sites’ findings until resolution, with the support of the study team
- Perform site staff training whenever needed during the study conduct
- Ensure close collaboration between all actors of clinical trial research, as a privileged link between investigational sites and the study team
- University degree or equivalent in Health Sciences
- Prior experience of at least 2 years as CRA
- Languages: English (written & spoken) is mandatory, and at least one other EU language (French, Dutch, German, Italian, Spanish) depending on the local projects and clinical sites.
- Excellent organisation
- Good communication skills
- Proactive, dynamic
- Independent and team-player