Looking for a job in clinical research where you can add value? Then quickly view our vacancies!
ClinTrial-Net (CT-N) is a young clinical contract research organization (CRO), based in Belgium. We provide Phase I-IV clinical development support services to the life sciences industry (biotechnology, pharmaceutical- and medical devices). Our mission is to accelerate the clinical development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
As our clinical activities are growing, we are looking for a 0.5-0.8 FTE freelance Senior CRA, experience in oncology is an asset, 80% home-based to join us. As a freelance Senior CRA, you will be responsible for the monitoring of clinical trials and tracking of study progress. You will contribute to the overall management of clinical trials in accordance with the appropriate quality standards including ICH-GCP guidelines, Standard Operating Procedures (SOPs), applicable regulations, rules and guidance. You will be responsible for clinical site start-up, maintenance, and closure activities, including maintenance of study documents.
* Conduct pre-study, initiation, monitoring, and closeout visits for research sites;
* Perform source document verification and eCRF review; regulatory document(s) collection and quality check review of essential documents (including PIS/ICF) ; conduct study drug inventory; adverse event and serious adverse event reporting and assess patient recruitment and retention.
* Assists with the ongoing management of the Trial Master File (TMF) and/or Investigator Site Files (ensuring essential documents are filed appropriately) and the maintenance / update of project-related data in an existing database, e.g. CTMS.
* Bachelor or Master of Science in a health-related / scientific field;
* 2-8 years of previous experience as a CRA and in Oncology;
* Fluent in the local languages (Dutch and French) and very good in English;
* Proven IT proficiency and skills including Microsoft Office.
* Effective time management and organizational skills
Are you looking for variety in your daily work or for something additional? If you find clinical research appealing, then we have a great opportunity for you.
As a young and dynamic company that supports doctors/hospitals in carrying out clinical studies, we are looking for a part-time study nurse.
Contact
Address
Sluisstraat 79
3000 Leuven
Belgium
Leopoldslei 209
2930 Brasschaat
Belgium