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cra i

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Sydney, New South Wales, Australia ICON Full time

As a CRA II you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

  • Serves as the main point of contact and site manager throughout all study phases.
  • Builds and maintains strong site relationships to ensure continuity across the trial.
  • Manages site activities in line with ICH-GCP, sponsor SOPs, local regulations, and study protocols.
  • Develops deep knowledge of the study protocol and procedures.
  • Collaborates with internal teams to prepare sites for activation (Site Ready).
  • Contributes to site selection and qualification processes.
  • Conducts on-site and remote monitoring to ensure data integrity and subject safety.
  • Performs site visits (e.g. initiation, monitoring, close-out) and documents findings promptly.
  • Handles regulatory documentation throughout study lifecycle.
  • Supports sites on protocol compliance, recruitment, deviations, audits, and performance issues.
  • Coordinates with internal functions (e.g. regulatory, PV, legal) and external stakeholders (vendors, IRBs, authorities).
  • Maintains systems (CTMS, eTMF) and ensures timely documentation.
  • Supports or leads audits and inspections.
  • Participates in co-monitoring as needed.

You are:

  • B.A./B.S. preferred with strong emphasis in science and/or biology

  • Min. 1 years of direct monitoring experience

  • Previous experience in oncology trials or ready to monitor oncology trials will be an asset

  • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor/lead
  • Hands on knowledge of Good Documentation Practices
  • Proven Skills in Site Management including independent management of site performance and patient recruitment
  • Demonstrated high level of monitoring skill with independent professional judgment
  • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
  • Ability to understand and analyze data/metrics and act appropriately
  • Experience with conducting site motivational visit designed to boost site enrollment
  • Capable of managing complex issues, working solution-oriented
  • Performs root cause analysis and implements preventative and corrective action

What ICON can offer you:

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 additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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