XPE Pharma is looking to hire a CRA (m/f) for one of its clients, a major Pharmaceutical Industry company situated near Brussels (Belgium).

 

· Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to our client SOPs and/or client guidelines

· Recruit investigators for participation in clinical trials

· Negotiate study budgets with investigators

· Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites

· Review draft protocols for completeness and feasibility

· Develop Case Report Forms for clinical trials

· Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators' Meetings

· Prepare and process Serious Adverse Event (SAE) reports

· Prepare project management reports for clients, project personnel, and our client management

· Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries

· Resolve queries of CRF data with study site personnel

· Review Tables and Listings generated from study data

· Assist in writing Clinical Study Reports

· When allocated by study management, submit essential/required documents to a central IRB or a country's central Ethics Committee, and, if necessary based on local requirements, the Competent Authority

 

 

· University or higher non-university degree in a paramedical science

· A minimum of 2 years experience in field monitoring or equivalent experience is required

· Excellent organizational skills,

· Ability to manage time and work independently

· Excellent written and oral communication skills in Dutch, French & English