Clinical Research Associate Role
The role of the Clinical Research Associate is to ensure the rights and well-being of trial participants are protected, and that reported trial data are accurate, complete, and verifiable from source documents.
Key Responsibilities:
* Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient management of clinical trials.
* Foster internal and external customer relationships to focus on project delivery as per study requirements and timelines.
* Collaborate with regulatory teams to prepare site essential documents and support ethics and regulatory submissions and approvals.
* Understand applicable local and international regulatory requirements relevant to specific clinical trials.
* Monitor investigational sites as per ICH GCP guidelines, covering all monitoring visit types across all phases of a clinical trial.
Requirements:
* CRA II: minimum of 6 months of independent CRA monitoring experience
* CRA III: 2+ years of independent CRA monitoring experience
* SCRA: minimum of 4 years of independent monitoring experience
* Full unrestricted working rights in Australia
Benefits:
We offer a great workplace, committed to being an employer of choice for gender equality and providing an inclusive work environment. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities.