Country Study Start-Up Specialist I/II

🔥 23 hours ago

🇪🇸 Spain – Remote

⏰ Full Time

🟢 Junior

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Inform the Regulatory Affairs Study Start-Up department about changes to Drug Law, guidelines, and country-level submission requirements • Review and prepare local submission documents and submit them to Ethics Committees and Competent Authorities for Clinical Trials/RWE • Deliver final submission packages to the assigned RASSU Specialist • Identify relevant Ethics Committees and Competent Authorities and process pre-payments • Adapt study-related documents to local country specifications in cooperation with the assigned RASSU Specialist • Serve as applicant and potential main point of contact for Ethics Committees, Competent Authorities, and the assigned RASSU Specialist • Communicate regulatory outcomes to the assigned RASSU Specialist • Upload and process complete study documentation in start-up modules, trackers, and study-specific TMF systems • Perform quality control and quality assurance of regulatory documents and reports • Perform review, reconciliation, close-out, and archiving activities • Oversee translation of regulatory documents when needed • Attend internal and external study meetings and provide regulatory status reports • Foster relationships with key contacts at study sites • Facilitate contract-related communication between sites and CTI • Assist with site contract translation, tracking, and execution • Maintain internal systems, databases, and tracking tools, including Trial Interactive • Identify investigator-, country-, and site-specific issues and ancillary agreement needs • Identify site personnel responsible for budget proposals and establish relationships • Interact with project management team members and clinical trials budget manager • Complete site-specific budget templates and train sites on their contents • Communicate site budget changes between sites and clinical trials budget managers • Assist with budget translation, tracking, draft and final version sharing, and delivery of final negotiated budgets

🎯 Requirements

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

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Dedicated training department • Ongoing education support • Hybrid work opportunities • CTI Cares community and charitable opportunities • Work contributing to life-changing treatments for patients with chronic and critical illnesses