Global Regulatory & Site Activation Specialist

WCT Serviços De Pesquisa Clínica Ltda. (Brazil); Argentina; A distancia; ARS 44.661.000 - 89.322.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials is seeking a Regulatory Start-Up Specialist to support end-to-end site start-up, activation and maintenance for global studies. You will act as the primary site contact and coordinate regulatory submissions, essential documents, and country-specific requirements.

The role requires strong organizational skills, regulatory knowledge, and ability to communicate with sites and RAMs. Fluency in English and familiarity with ICH GCP are preferred.

Formación

• Minimum 2 years of experience in clinical research, preferably in site activation and/or regulatory‑related function.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations.
• Multilingualism preferred; fluent in local language; working knowledge of English.
• A minimum 2-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science

Responsabilidades

• Responsible for supporting end‑to‑end site start‑up from site identification to site activation and maintenance serving as the primary point of contact for the site
• Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
• Review and provide advice on country timelines for the assigned studies
• Provide local QC of submission dossiers prior to dispatch
• Maintain regular communication with sites to ensure timely completion of start‑up and maintenance activities

Conocimientos

Organizational skills

Planning & scheduling

Regulatory processes knowledge

Communication skills

Issue identification

Cultural/regulatory knowledge

Adaptability

Team collaboration

Multitasking

MS Office

Digital systems aptitude

Educación

Science college education

Herramientas

MS Office

Descripción del empleo

Worldwide Clinical Trials is seeking a Regulatory Start-Up Specialist to support end-to-end site start-up, activation and maintenance for global studies. You will act as the primary site contact and coordinate regulatory submissions, essential documents, and country-specific requirements.

The role requires strong organizational skills, regulatory knowledge, and ability to communicate with sites and RAMs. Fluency in English and familiarity with ICH GCP are preferred.