Dorota Stefanicka - Wojtas

Experience

• 

  Lower Silesian Foundation for Regional Development

  Sept 2009 - Nov 2017

  Cooperator
• 

  Lower Silesian Political and Economic Forum

  Sept 2009 - Nov 2017

  Project Coordinator
• 

  Stem Cells Spin S.A.

  Jul 2010 - Nov 2017

  • Marketing and Sales Manager

    Mar 2014 - Nov 2017

  • Marketing and Public Relations Specialist

    Jul 2010 - Mar 2014
• 

  Wroclaw Medical University

  Nov 2017 - now

  -comprehensive management, supervision and implementation of the international clinical trials -ensureing that studies are conducted, recorded and reported in accordance with the Sponsor’s requirements, protocol, standard operating procedures (SOPs), ICH-GCP and applicable requirements-overall coordination and management of non-comercial clinical trials, responsibility for ongoing clinical trials-risk management and problem solving-overall responsibility for planning goals and tasks in clinical trials and their completion in accordance with applicable procedures-coordinate the development of new clinical research project proposals from multiple funding sources-create - in collaboration with the legal department - tripartite contracts, in collaboration with subcontractors, documentation for clinical trials-negotiation and oversee the contracts with sites, PI -prepare study budgets-monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project-ensure the highest quality at all levels of project realization-project status reporting -verification of CRF-monitor databases-co -conduct of monitoring visits (initial, routine monitoring) - ensure the study is being conducted in accordance with the protocol, SOPs, GCP and applicable regulatory requirements-ensure completion and maintenance of study documentation-ensure access to training materials and appropriate learning tools-cooperation with Study Team, PI in order to meet trial’s guidelines and deadlines preparation-review of management plans for individual studies-continually update knowledge of procedures and policies-develops collaborative relationships with investigative sites and client company personnel-prepare reports to funding bodies-oversee the payments -attending Investigator meetings-main point of contact for Sponsors, attend Sponsor’s meeting, maintain positive relations with the Sponsors Show less

  • Research Assistant

    Jan 2024 - now

  • Clinical Research Associate

    Dec 2022 - now

  • Clinical Research Coordinator

    Jan 2021 - now

  • International Project Manager

    Nov 2017 - Jan 2021