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 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. 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. 

More precisely your main responsibilities will be the following, but not limited to :

• 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 of sites and close follow-up (emails, phone calls and remote meetings)
• 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

In addition to these responsibilities, you will also be involved in:

• Sites identification, feasibility and selection with the CPL
• Synopsis/protocol writing and set-up phase with the CPL
• Submission to Ethics Committees and Competent Authorities with the CPL
• eCRF design with the DM
• Safety management and tracking with the CPL (SAE and safety reports)

Your Profile

• Scientific background (BACHELIER or MASTER in Life Sciences)
• Extensive knowledge of clinical research
• 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