O Joanna

Biography

"Junior Clinical Research Associate Company NameBrillance Sp. z o.o. Dates EmployedJan 2017 – Present Employment Duration9 mos LocationKraków, woj. małopolskie, Polska Reviewing, translating and managing of study-related documents Obtaining of Pre-study Forms and documents from study site staff, preparing/completing of Submission Files as well as sponsor-related pre-study document packages. Assisting to SCRA or PM/COM in Contracts preparation. Preparing Ethics Committees submissions, communicating with the ECs and managing of further EC-related documentations. Preparing of Regulatory Submission and assisting in completing of CTA. Preparing and submitting of amended study documents to Regulatory Office, Ethics Committee and to study staff. Managing of study–related trainings of site staff, assistance in organization of Investigator and Monitor Meetings. Conducting Pre-study Visits, Initiation visits and Close-Out visits under supervision. Conducting of regular Monitoring visits in strict compliance with applicable Monitoring plan, Monitoring guidelines or other relevant study guidelines, as well as other basic documents Regular reporting according to Sponsor requirements as well as Brillance’s requirements. Immediate reporting of critical issues requiring resolution Calculating of investigators/site contractual fees and transferring them for review and approval to PM. Attending interim trainings on study updates, providing or assisting in providing of continual site staff training according to actual need, or according to Sponsor’s request. Attending Brillance meetings for purposes of control and further education. Continuous interactive co-operation with other Brillance, Sponsor or Sites staffs to co-ordinate successfully study preparation, conduct and close-out fulfilling all applicable global and local or contracted requirements. "

Research Interest

clinical research