Country Study Start-Up Specialist I/II

This is a fully remote position, open to applicants in Spain.

📋 Description

• Notify the Regulatory Affairs Study Start-Up team about updates to Drug Law, guidelines, and submission requirements at the country level.

• Review and prepare local submission documents for submission to Ethics Committees and Competent Authorities related to Clinical Trials/RWE.

• Deliver final submission packages to the designated RASSU Specialist.

• Identify relevant Ethics Committees and Competent Authorities and manage pre-payment processes.

• Modify study-related documents to align with local country requirements in collaboration with the designated RASSU Specialist.

• Act as the applicant and primary point of contact for Ethics Committees, Competent Authorities, and the assigned RASSU Specialist.

• Relay regulatory outcomes to the assigned RASSU Specialist.

• Upload and manage comprehensive study documentation within start-up modules, trackers, and study-specific TMF systems.

• Conduct quality control and quality assurance for regulatory documents and reports.

• Carry out review, reconciliation, close-out, and archiving tasks.

• Supervise the translation of regulatory documents when necessary.

• Participate in internal and external study meetings and provide updates on regulatory status.

• Build and maintain relationships with key contacts at study sites.

• Facilitate communication regarding contracts between sites and CTI.

• Assist with the translation, tracking, and execution of site contracts.

• Maintain internal systems, databases, and tracking tools, including Trial Interactive.

• Identify issues specific to investigators, countries, and sites, as well as ancillary agreement requirements.

• Identify site personnel responsible for budget proposals and establish connections.

• Collaborate with project management team members and the clinical trials budget manager.

• Complete site-specific budget templates and provide training to sites on their contents.

• Communicate changes in site budgets between sites and clinical trials budget managers.

• Assist with the translation, tracking, and sharing of draft and final versions of budgets, and ensure delivery of finalized negotiated budgets.

⛳️ Requirements

• 1-2 years of experience in Clinical Research (pharmaceutical, site, or CRO service).

• Experience in regulatory processes within the country.

• Associate’s or Bachelor’s Degree in an allied health field such as nursing, pharmacy, or health science, or equivalent relevant experience.

• Proficient in both spoken and written Italian and English.

• Applications must be submitted in English.

🏝️ Benefits

• Structured mentoring program.

• Leadership development courses.

• Dedicated training department.

• Ongoing education support.

• Hybrid work opportunities.

• CTI Cares community and charitable initiatives.

• Work contributing to life-changing treatments for patients with chronic and critical illnesses.