WhatYou'llDo:Support of Regulatory Affairs Study Start-Up (RASSU) department:Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country levelReview/prepare local submission documents and performs submissions (Initial submissions, Substantial Amendments and Notifications etc.) to Ethics Committees (Central and Local) and to Competent Authority for Clinical Trials/RWE in accordance with local country requirements (e.G. via portal upload or mail or Email); and deliver final submission package to RASSU Specialist assigned to the studyIdentify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process pre-payments toEthics Committees and Competent Authority; adapts study-related documents (e.G. Informed Consent Forms)



to meet each local country's specifications in cooperation with the RASSU Specialist assigned to the studyServe as applicant for Clinical trials/RWE and may act as main point-of-contact for the Ethics Committees and Competent Authority and the assigned RASSU Specialist to the study on the country levelCommunicate closely with RASSU specialist assigned to the study regarding EC /CA outcomesAccurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paperQC and QA of various study related Regulatory documents and reportsPerform review, reconciliation, close-out, and archiving activities of study or projectOversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scopeAttends internal and external study meetings and regulatory status reports for each site and country during study meetingsSupport the CTI Legal team:Foster relationships with key contacts at each siteFacilitate contract-related communication between the site and CTIAssist with site contract translation; track t

📌 Country Study Start-Up Specialist I/ Ii (España)
🏢 Cti
📍 España