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Study Start Up Associate II

ICON · Sao Paulo, Brazil

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Clinical OperationsFull-timeCompany career page

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Role summary

Study Start Up Associate II role at ICON supporting North American clinical trial initiation. Responsibilities include regulatory document preparation, stakeholder coordination, and guidance on trial start-up compliance. Position based in São Paulo, Brazil.

What they're looking for

  • Bachelor's degree in life sciences or related field
  • Minimum 2 years clinical research or regulatory affairs experience
  • Proven site start-up and activation experience
  • Strong knowledge of ICH-GCP and local regulatory requirements
  • Demonstrated experience managing ethics submissions for U.S. clinical studies
  • Strong project management and organizational skills
  • Excellent communication and cross-functional collaboration abilities

What you'll be doing

  • Lead preparation and submission of regulatory documents and ethics committee applications
  • Coordinate with internal and external stakeholders for study approvals and authorizations
  • Maintain accurate records of regulatory submissions, approvals, and correspondence
  • Provide guidance to study teams on regulatory requirements and start-up best practices
  • Participate in process improvement initiatives to enhance study start-up efficiency

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Date posted10 days ago
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