Experience

Robarts Clinical Trials
• Netherlands
• Research Services
• Lead CRA

  • Apr 2013 - Present

Alzheimer Nederland
• Netherlands
• Non-profit Organizations
• 100 - 200 Employee
• Office assistant

  • Jan 2013 - Apr 2013


TFS Trial Form Support

• Sweden
• 1 - 100 Employee

• Clinical Research Associate

  • May 2008 - Jun 2012

  Involved in site management of sponsored clinical trials. - Worked on different trials in several trial phases: o 2 phase-I trials, on topical antibiotics. o 1 phase-II trial, on a biological for Crohn’s disease. o 4 phase-III trials; 2 on a meningococcal B vaccine and 2 on bio-surgery, Matrix-induced Autologous Chondrocyte Implantation - Managed up to 2 studies with 13 sites at once. - Extensive experience with report-writing and on-site visits: o 11 pre-study visits o 21 initiation visits o 254 monitoring visits o 41 close out visits o 2 audits - Worked internationally on projects in Germany (2,5 years), the Netherlands (1,5 year) and Belgium (0,5 year). - Worked for both bigger and smaller sponsors, as part of the CRO, or as being seconded to a pharmaceutical company directly. - Experience with feasibility studies. - Experience with Investigator Site File and Trial Master File management. - Experience with the submission of new studies and/or study related materials to Institute Review Board / Ethics Committees and Authorities in the Netherlands, Germany and Belgium. - Worked closely with pharmacovigilance and QA departments. - Experience with reviewing/adjusting Patient Informed Consent forms. - Experience with contract negotiations. - Familiar with the European Directives on GCP and clinical trials as well as FDA guidelines. - Familiar with local legislation concerning clinical trials in the Netherlands and Germany and Belgium. - Attended various trainings on GCP and other topics related to clinical research: o Pharmacovigilance o Monitoring advance o Monitoring basic o Effective site management o Good clinical practice o Audits and inspections