Study Start-Up Specialist I​/II

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

• Foster relationships with key contacts at each site
• Facilitate contract-related communication between the site and CTI
• Assist with site contract translation; track the progress by updating and maintaining internal systems, databases and tracking tools (including the Trial Interactive database) with project specific information
• Identify any unique investigator, country or site-specific issues and identifying any ancillary agreements that may be necessary
• Assist with site contract execution

• Identify and establish relationship with site personnel responsible for budget proposals
• Interact with project management team members and clinical trials budget manager
• Has exact knowledge about site specific budget templates and experiences of completing such templates
• Train sites to understand budget templates and contents
• Understand and communicate changes made by the site to clinical trials budget managers and vice versa
• Assisting with translation, tracking the progress by updating the Trial Interactive database, sharing drafts and final versions with CTI personnel and delivering the final negotiated budget to site personnel

• 1-2 years of experience in Clinical Research (pharmaceutical, site or CRO service) and experience in regulatory in country.
• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• Fluent in spoken and written Italian and English

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