Clinical Research Associate II

4 weeks ago

Brisbane, Queensland, Australia Pharmiweb Full time
Study Start Up Associate II

At ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a Study Start Up Associate II to join our diverse and dynamic team.

Key Responsibilities:
  • Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
  • Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  • Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
  • Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
  • Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Requirements:
  • Bachelor's degree in life sciences or a related field.
  • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
  • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
  • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

What ICON Offers:
  • Competitive salary.
  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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