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Support of Regulatory Affairs Study Start-Up (RASSU) department
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- Informs the RASSU department about any change of Drug Law/guidelines and updated requirements for submission on the country level
- Review/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 study
- Identify the Central and Local Ethics Committees and Competent Authority needed for the study on the country level; process pre-payments to Ethics 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 study
- Serve 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 level
- Communicate closely with RASSU specialist assigned to the study regarding EC /CA outcomes
- Accurately 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 paper
- QC and QA of various study related Regulatory documents and reports
- Perform review, reconciliation, close-out, and archiving activities of study or project
- Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
- Attends internal and external study meetings and regulatory status reports for each site and country during study meetings
Sup
📌 Country Study Start-Up Specialist I/ II (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid
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