Clinical Research Associate
Il y a 4 mois
We are looking for a motivated person to perform monitoring visits and assist Clinical Project Leaders (CPLs) in clinical operations. The role will require travel mainly in Belgium. As a CRA for Artialis you will be an important member of the clinical team and you will work closely with Clinical Project Leaders and the Data Manager on different clinical trials.
Artialis is a European Contract Research and development Organization (CRDO), offering customized solutions from preclinical (in-vitro and in-vivo), clinical to post marketing studies, including a wide range of biomarkers to support the development of healthy ageing products (pharmaceuticals, medical devices, food supplements).
Artialis’ mission is to provide high quality, affordable and innovative services meeting the regulatory requirements accelerating and reducing costs from our partners for their product development to access market.
Our values are trust, respect, excellence and passion.
Artialis is hiring a Clinical Research Associate (CRA) fluent in French and as preferably fluent in Dutch who is available immediately.
We are looking for a motivated person to perform monitoring visits and assist Clinical Project Leaders (CPLs) in clinical operations. The role will require travel mainly in Belgium.
As a CRA for Artialis you will be an important member of the clinical team and you will work closely with Clinical Project Leaders and the Data Manager on different clinical trials.
You will be under the responsibility of the Head of Clinical Operations. Artialis being a full services company, you will have the chance to be closely involved in each important step of a clinical trial including protocol writing, regulatory activities, sites management including feasibilities, SIV, MOV, COV, trial essential documentation, Trial Master Files management, biological samples management and data management.
- First line contact with investigating sites
- Preparation and management of trial essential documentation
- Sites initiation, monitoring and close-out mainly in Belgium (Flanders, Wallonia and Brussels), including preparation and reports
- New sites/clinical staff training
- Management and shipment of clinical materials, (amended) trial essential documentation and Investigational Product (IP)
- Management, tracking and resolution of protocol deviations, queries and issues
- Set-up, maintenance and close-out of all study files (electronic or paper TMF and ISF)
- Close communications with sites, subcontractors, COO, CPL and Data Manager
- Contribution to the maintenance of Artialis’ clinical standard operation procedures (SOP) in accordance with the principles of ICH GCP and ISO 14155
Your Profile
- Scientific background (BACHELIER or MASTER in Life Sciences)
- Extensive knowledge of clinical research
- At least 2 years of experience as a CRA
- GCP extend knowledge and training
- Fluent in French and as preferably fluent in Dutch
- Good knowledge of English (written and spoken)
- Soft skills
- Willingness to integrate a small structure where versatility and flexibility are key factors
- Ability for quick adaptation and autonomy
- Team spirit and able to collaborate closely with CPL and DM
- Capacity to plan, set priorities and manage time
- Good verbal and written communication skills in English, French and preferably speaking & reading in Dutch
- Personal qualities: motivation, reliability, rigorous, sociability
**Offer**:
The contract is for a full-time and hybrid job. You will be a key player in an enthusiastic, scientific and motivated team, where you can grow and directly contribute to the success of the company.
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