Clinical Research Associate

2 weeks ago

Melbourne, Victoria, Australia Pharmiweb Full time
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring and managing clinical trials within the Oncology department.

Key Responsibilities
  • Monitor and manage multiple trials within Oncology, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
  • Develop and maintain site start-up documents, including Site Initiation Visit (SIV) agendas.
  • Provide training and support to Site Managers (SMs) on study protocols and procedures.
  • Represent Local Trial Managers (LTMs) or SMs on Site Management Teams (SMTs) and meetings.
  • Take over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial.
  • Support country budget development and/or contract negotiation in liaison with CCS colleagues.
  • Assist with Adverse Event (AE) reporting and metrics/KPIs management.
Requirements
  • Bachelor's degree in Biological Sciences or equivalent.
  • Minimum 2-3 years' experience in monitoring pharmaceutical industry clinical trials.
  • Minimum 1-3 years' experience monitoring Oncology trials.
  • Knowledge of several therapeutic areas.
  • Analytical/risk-based monitoring experience is an asset.
  • Ability to actively drive patient recruitment strategies at assigned sites.
  • Ability to partner closely with investigator and site staff to meet all study timelines.
  • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
  • Strong communication and influencing skills to effectively manage study sites both remotely and face-to-face.
  • Strong team member and self-starter with the ability to work independently.
  • Knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
  • Ability to travel up to 50%.
What We Offer
  • Competitive salary range ($89,376.00 USD - $111,720.00 USD).
  • Annual leave entitlements.
  • Range of health insurance offerings.
  • Competitive retirement planning offerings.
  • Global Employee Assistance Programme.
  • Life assurance.
  • Flexible country-specific optional benefits.

At ICON, we value diversity, inclusion, and belonging. We are committed to providing an inclusive and accessible environment for all candidates. If you require reasonable accommodations during the application process, please let us know through our reasonable accommodations form.

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