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Senior Clinical Research Associate

1 month ago

Darwin, Northern Territory, Australia Pharmiweb Full time
Job Summary

We are seeking a highly skilled Senior Clinical Research Associate to join our team in Oncology trials. As a key member of our team, you will be responsible for monitoring and managing clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice guidelines.

Key Responsibilities
  • Monitor and manage multiple clinical trials within Oncology, ensuring timely completion and high-quality data.
  • Develop and implement site start-up documents, including SIV agendas, to ensure smooth trial execution.
  • Provide training and guidance to junior team members, promoting knowledge sharing and best practices.
  • Act as a lead Site Manager, training and mentoring other Site Managers on study protocols and procedures.
  • Represent the team in meetings and discussions, ensuring effective communication and collaboration.
  • Support country budget development and contract negotiation, working closely with CCS colleagues.
  • Assist with ASV and metrics/KPIs, ensuring alignment with the Quality Oversight Plan.
Requirements
  • Minimum 3 years' experience in monitoring pharmaceutical industry clinical trials, with a focus on Oncology.
  • Strong analytical and risk-based monitoring skills, with experience in various therapeutic areas.
  • Ability to drive patient recruitment strategies and partner with investigators and site staff to meet study timelines.
  • Excellent communication and influencing skills, with experience in managing study sites remotely and face-to-face.
  • Knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
  • Ability to travel up to 50%.
What We Offer
  • Competitive salary range ($98,312 - $122,890 USD).
  • Annual leave entitlements, health insurance, retirement planning, and other benefits.
  • Opportunities for professional growth and development, with a focus on diversity, inclusion, and belonging.