Clinical Research Associate

4 weeks ago

Canberra, ACT, Australia Pharmiweb Full time
Key Responsibilities:

As a Study Start Up Associate at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

  • Prepare and submit 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:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of benefits, including various annual leave entitlements, health insurance, retirement planning, and more.

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