Regulatory & Start Up Specialist - Execute Feasibility and Site Identification

Há 2 dias

São Paulo, São Paulo, Brasil beBeeStartUp Tempo inteiro R$80.000 - R$112.000

Job Title: Regulatory & Start Up Specialist

The Regulatory and Start-up Specialist role requires executing feasibility, site identification, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. This position serves as a Single Point of Contact (SPOC) for assigned studies, working closely with the Site Activation Manager, Project Management team, and other departments as necessary.

Key Responsibilities:

  • Perform feasibility, site activation, and some maintenance activities for investigative sites according to applicable regulations, SOPs, and work instructions.
  • Prepare site documents, reviewing for completeness and accuracy.
  • Inform team members of completion of regulatory contractual and other documents for individual sites.
  • Distribute completed documents to sites and internal project team members.
  • Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project-specific information.

Qualifications and Skills:

  • Bachelor's Degree in Life Sciences or a related field.
  • 1-2 years of experience in clinical research regulatory and specific experience with CEP/CONEP, ICF, ANVISA, and English language skills.
  • Advanced level of English skills.
  • Great communication skills and ability to work in a team.

About the Role:

This is an exciting opportunity to join our team as a Regulatory & Start Up Specialist, where you will be responsible for executing feasibility, site identification, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements.

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