Łukasz Jedynak

Site selection, Pre-study visits, ICF preparation, study budget preparation and management, contracts negotiation with sites/investigators, submission to RA and EC, Initiation visits, local study management , Periodic Monitoring visits, Payments, Closure Visits, Archiving.

Feasibility, Sites selection, Qualification visits, Initiation visits, Monitoring visits, Close out Visits, Payments, Archiving, support of IMPACT

Performance of QC duties in accordance with SOP, Enter the correction before submission of data to QA, Implementation audit plans related to QC during trials conducting, Implementation of QC activity in accordance with the schedule of clinical trial, Making essential correction and cooperation with employees responsible for appropriate amendments, Follow up of unresolved adverse event with Principal Investigator to QC during trials conducting, Implementation of QC activity in accordance with the schedule of clinical trial, Direct cooperation with Sponsor / Sponsor’s representative responsible for external monitoring, Reports conformity check with source documentation, Cooperation with Site Coordinator regarding preparing medical documentation, Source data verification, CRF monitoring, Help in maintain and update all the systems and SOPs in the QC department, Train the staff on SOPs related document control and Internal quality checks, Ensure proper documentation of AE, Note to files, Deviations etc., Follow up of unresolved adverse event with Principal Investigator,