Our client is a global pharma company located at the east side of Brussels.
This function can be partially home based.
The CRA is responsible for the proper conduct of the study according to protocol, ICH-GCP and all applicable requirements
- To perform submissions to ECs and CAs: initial submissions, amendments and safety information amongst other.
- To prepare, conduct and report feasibility studies.
- To prepare, conduct and report site selection, initiation, monitoring and close-out visits.
- To build and maintain good collaboration with investigators and site personnel.
- To ensure that sites are prepared and ready to conduct the study in relation to training, study supplies, medication amongst other.
- To verify source data and CRF on completeness and correctness, in compliance with the requirements as set out in the monitoring manual.
- To monitor the conduct and progress of the study.
- To collect, maintain and archive all required essential documents.
- To verify IP ordering, shipments, storage and accountability.
- To verify whether safety reporting requirements are met: SAE, SUSAR, line listings.
- To report adequately and timely to the appropriate person on the progress of the study and on any item requiring follow-up.
- To coordinate communication between site staff and any other party.
- To participate in international study teams.
- To work, when possible, in a pro-active/anticipating manner to avoid problems from occurring.
- To work in accordance with the specified quality management system for the study and to adhere to study timelines.
- To coordinate audit and inspection preparation activities when required and ensure that corrective and preventive actions are implemented.
- To track payments to the sites.
- At least 1 year experience as CRA
- Preferably experience in oncology
- Medical/scientific academic degree or suitable experience
- Good verbal and written communication (Dutch, French and English)
- Good organizational and planning skills