Regulatory Start-Up & Site Activation Specialist

WCT Serviços De Pesquisa Clínica Ltda. (Brazil); Argentina; A distancia; ARS 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Argentina is seeking a regulatory start-up specialist to serve as the local point of contact for submissions, site activation and maintenance on awarded projects. You will plan, initiate and track essential documents to meet country requirements and site activation goals.

You will coordinate country-specific patient information materials, inform the RAM of timelines and risks, and support regulatory intelligence while ensuring compliance with ICH GCP and SOPs.

Formación

• Minimum 2 years of experience in clinical research.
• Experience in site activation and/or regulatory functions preferred.
• Knowledge of ICH GCP and country regulations.
• Fluent in local language; working knowledge of English.

Responsabilidades

• Lead regulatory submissions and site activation planning.
• Coordinate essential document collection and reviews.
• Act as country-level regulatory contact for assigned studies.
• Maintain communication with RAM and project teams.

Conocimientos

Multilingualism

English proficiency

MS Office

Communication skills

Regulatory knowledge

Site activation experience

Educación

Two-year college curriculum in life sciences

Herramientas

MS-Office

Descripción del empleo

Worldwide Clinical Trials in Argentina is seeking a regulatory start-up specialist to serve as the local point of contact for submissions, site activation and maintenance on awarded projects. You will plan, initiate and track essential documents to meet country requirements and site activation goals.

You will coordinate country-specific patient information materials, inform the RAM of timelines and risks, and support regulatory intelligence while ensuring compliance with ICH GCP and SOPs.