FLUIDDA is the leading company in the research and development of respiratory imaging biomarkers. Collaboration with universities and medical research centers resulted in clinical trials including a total of 1250 patients. Founded in 2005, FLUIDDA has proven to be a young and highly innovative company improving drug development and patient care using Advanced Medical Imaging.
In order to alleviate the growing business we are currently looking to strengthen our team with a Clinical Research Associate. The Clinical Research Associate ensures compliance with the clinical trial protocol, checks the clinical site activities by conducting on-site visits. The Clinical Research Associate reviews the Case Report Forms and Source documents to make sure no discrepancies are present.
- Good sense for structure and accuracy
- Strong in administration
- Quick learner
- Good PC Skills
- Fluent in Dutch and English
- Paramedical or scientific background, previous experience in clinical research is an asset.
- Review and creation of trial related documentation (monitoring reports, monitoring plan, e-CRF completion guidelines,..) and files
- Follow-up on submissions to Ethics Committee and Competent Authorities
- Organization of study start-up and site initiation meetings together with a multidisciplinary team
- On site monitoring of the Case Report Forms, Source documents, Investigator files, Medication binders and general documentation
- Monitoring and validation of study data, on site or in-house
- Follow-up on recruitment
- Communication towards clients and study sites, sending follow-up e-mails and review corrective actions
- Contribute to the development and improvement of departmental procedures and processes/templates in the scope of the company’s effort towards continuous quality improvement
- Perform miscellaneous job-related duties as assigned
You can expect a job with growth potential in a company with great perspective and highly motivated colleagues. We offer a salary in accordance with your age and experience and extra-legal benefits.