Clinical Research Associate

2 weeks ago

Sydney, New South Wales, Australia BeiGene Full time

About the Role:

The Clinical Research Associate will be responsible for monitoring activities related to initiation, conduct, and timely completion of Oncology and Hematology clinical trials within the country.

The ideal candidate will deliver data within timelines and required quality standards, adhering to monitoring procedures in accordance with GCP and ICH, local regulations, and SOPs.

Key Responsibilities:

  • Conducts monitoring visits, including pre-study, initiation, routine monitoring, and closeout visits, as required.
  • Ensures study milestones for sites are met as planned, including study startup, recruitment, database analysis, and closeout.
  • Documents monitoring activities appropriately, following ICH-GCP and BeiGene standards.
  • Attends training sessions, including onboarding, disease indication, and project-specific training, as required.
  • Collaborates with CRA Group/CRM to ensure recruitment plans and execute contingency plans, as needed.

Requirements:

  • Bachelor's level degree or above in life sciences, pharmacy, nursing, or medicine.
  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.
  • +1 year of monitoring experience in the pharmaceutical or CRO industry.
  • Excellent communication and interpersonal skills.
  • Fluent in English (writing and speaking).

What We Offer:

  • Market competitive compensation package, including a performance-based annual bonus scheme.
  • Company shares, including a generous welcome grant and performance-based annual equity plan.
  • In-house and external learning and development opportunities.
  • Fantastic benefits program and ongoing improvements.

BeiGene Global Competencies:

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

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