What You’ll Do
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 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

Support the CTI Legal team

Foster relationships with key contacts at each site

Facilitate contract-related communication between the site and CTI

Assist with site

📌 Country Study Start-Up Specialist I/ II (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid