Barbara Donabauer

Prepare & coordinate international clinical trials in CEE countries; manage clinical trial preparation & progress; establish and supervise relationship with investigators; counsel and guide CRAs and CROs; review trial related documents and reports; plan study budget, timelines and capacities; ensure timely submission to ECs & CAs; train and lead the CTCs & CRAs; supervise monitoring activities and perform co-monitoring; organize & conduct investigator meetings

Study Monitoring CRO supervision Advicing in GCP issues Organization of investigators' meetings and training of investigators and study nurses Contribution to protocol, CRF development and report writing Development and revision of SOPs SOP training

Contribute to study set-up; Selection, management and supervision of CROs and sites; Coordination and supervision of CRAs; GCP and study specific training for investigators, site staff, CRAs and CROs; Maintenance of the study master file (set-up, review of documents and filing); Performance and supervision of qualification, initiation, monitoring and close-out visits; Management of investigational product (including labelling) and overall drug accountability; Interaction with regulatory departments (at the

Member of the project team for a study for the Ministry of economics (Biotechnology for the production of market relevant chemicals from reproductive material-determination of the research requirements, technical feasibility and market potential). The project included literature reseach, a stay in Brazil (visit of selected production plants, univerity and research institutes) and writing a scientific report.