Introduction
You have a medical/science background, are perfect bilingual (ENG + one other EU language, like French, Dutch, German, Italian, Spanish), are flexible to travel through Belgium and Europe ?
Company/Department
Our client is an international company active in the academic research in cancer care.
Function information
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.
Main responsibilities / Major Activities
- 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 and regulatory obligations
- Address issues in a manner that is beneficial for the site and the intern team
- Report the findings of the “on-site” monitoring visits according to intern Standards
- Follow the sites’ findings until resolution, with the support of the intern study team and Quality Assurance and Control unit
- Perform site staff training whenever needed during the study conduct
- Ensure close collaboration between all actors of clinical trial research, as a privilege link between investigational sites and the intern study team.
Requirements
- University degree or equivalent in Health Sciences
- Practical knowledge of the conduct of clinical trials
- Prior experience of at least 2 years as CRA and prior experience in Oncology
- Ability to travel 50% of working time across European countries
- Languages: English (written & spoken) is mandatory, and at least one other EU language (French, Dutch, German, Italian, Spanish)
- Excellent organization
- Good communication skills
- Independent and team-player.
Offer
A long term contract full time within a research company in Brussels: junior package with insurances, mealvouchers, transport, laptop and mobile phone.
Information
Sybille Ponet
sybille.ponet@xpepharmascience.com
02/801.16.65