Clinical Trial Associate

6/2016 – 10/2017

• Responsible for monitoring an Oncology Study with 74 patients included;
• Responsible for Observational Studies;
• Support the Clinical Project Manager;
• Responsible for identification of potential sites and for start-up activities;
• Development of Clinical monitoring plan;
• Quality Assurance;
• Regulatory Submission;
• On site and in house monitoring activities;
• Site Qualification activities;
• Monitoring activities;
• Vendors coordination
• Close-out activities;
• eTMF management;
• Regulatory documents collection;

Pharmazie

7/2011 – 12/2013

• Responsible for managing 20 sites in Brazil, 03 sites in USA and 03 sites in Portugal
• Responsible for identification of potential sites and for start-up activities
• Perform pre-study visits, contract and budget negotiation as well as preparation of regulatory package for ECs and follow up in regards to timelines completion
• Responsible for site initiation, monitoring and close out visits, preparation for database lock and audits
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
• Coordination of ordering/ dispatch and tracking of trial materials
• Update the Clinical Trial Management Systems
• Review of translated documents
• Report and follow up of SAEs

Projektorganisation

7/2009 – 12/2010

• Support the Clinical Research teams with ongoing conduct of studies
• Preparation, handling and tracking of Ethics/ Regulatory submissions
• Coordination of Investigator payments
• Coordination of ordering/ dispatch and tracking of trial materials e.g CRFs, Diary Cards, Lab Supplies, Drug Supplies as appropriate
• Update the Clinical Trial Management Systems
• Participate in Investigator’s and CRA Meetings
• Conduct study feasibilities

Projektassistenz