Country Study Start-Up Specialist I/ II

CTI Clinical Trial and Consulting Services; Madrid; Híbrido; EUR 48.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work opportunities

Mentoring program

Descripción de la vacante

CTI Clinical Trial and Consulting Services seeks a regulatory affairs professional to support RASSU start-up activities in a multinational environment. The role includes submitting to ethics committees and authorities, coordinating with the CTI legal team on site contracts and translations, and ensuring TMF accuracy.

The candidate will handle budgeting interactions with the project management team and translate documents as needed, with hybrid work opportunities and cross-country

Formación

• 1-2 years of experience in Clinical Research and regulatory in country.
• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science.
• Fluent in spoken and written Italian and English.

Responsabilidades

• Inform and update the RASSU department on regulatory changes and local submission requirements.
• Review/prepare local submission documents and perform submissions to Ethics Committees and Competent Authorities.
• Coordinate with CTI Legal team on site contracts and translations; manage tracking in internal systems.
• Assist with site budgets, templates, translations and progress updates in Trial Interactive database.
• Serve as applicant for trials and act as main point-of-contact for EC/CA and RASSU Specialist.
• QC/QA of regulatory documents and archiving activities; attend regulatory meetings.

Conocimientos

Clinical Research

Regulatory awareness

English proficiency

Italian proficiency

Educación

Health sciences degree

Descripción del empleo

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 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

Support Site Budget activities

• 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

What You’ll Bring

• 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

About CTI

• Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note

In light of recent increase in hiring scams, if you’re selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process