Site Regulatory Specialist

Há 5 dias

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$50.000 - R$80.000

**Site Activation Professional Role Summary:**

This role supports site activation activities, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.

The primary responsibilities include:

  • Reviewing documents for completeness, consistency and accuracy under guidance of senior staff
  • Preparing site regulatory documents reviewing for completeness and accuracy
  • Informing team members of completion of regulatory and contractual documents for individual sites
  • Distributing completed documents to sites and internal project team members
  • Supporting the updating and maintenance of internal systems databases tracking tools timelines and project plans with accurate and complete project specific information
  • Reviewing tracking and following up the progress approval and execution of documents regulatory ethics Informed Consent Form (ICF) and Investigator Pack (IP) release documents

**Key Qualifications Include:**

  • A high school diploma or equivalent
  • At least one year experience in regulatory and start-up area
  • Good interpersonal communication and organizational skills
  • General awareness clinical trial environment and drug development process
  • Ability to work on multiple projects
  • Establishing and maintaining effective working relationships with co-workers managers and sponsors

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