Study start up associate I – São Paulo/SP

Responsabilidades

• Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
• Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Maintaining accurate and up-to-date records of regulatory submissions and approvals.
• Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
• Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Requisitos

• QUALIFICAÇÕES MÍNIMAS
  • Bachelor’s degree in life sciences or a related field.
  • Strong attention to detail and organizational skills.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.
  • Willingness to travel as required (approximately 5%).
• QUALIFICAÇÕES PREFERENCIAIS
  • Previous experience in clinical research or regulatory affairs preferred, but not required.

Marcado como: Assuntos Regulatórios, Biociências, Compliance, Documentação, Estudos Clínicos, Normas Regulatórias, Pesquisa Clínica