Country Study Start-Up Specialist — Hybrid

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

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