For one of our pharmaceutical clients in Diegem, we are currently looking for a Clinical Research Coordinator. This person will provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas in accordance with all applicable regulations for Medical Devices. The Clinical Research Coordinator will plan and implement a monitoring program for all international regulatory and post marketing clinical research studies. He will maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good scientific practice.
- Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress
- Maintain the highest ethical, clinical and scientific standards, ensuring both the safety and well being of all trial participants and good/rigorous scientific practice
- Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees
- Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
- Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices
- Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials
- Administer the inventory of Investigational products and control the issue of investigational products to approved sites where necessary
- Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team
- Maintain compliance with Company SOP's