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ICON plc

Lead CRA

Reposted Yesterday
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In-Office
Sydney, New South Wales
Senior level
In-Office
Sydney, New South Wales
Senior level
Lead monitoring activities for APAC studies, ensure compliance, provide oversight, deliver training, and support project communications and issue resolution.
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Lead CRA, Home-based in Australia

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Role: Lead CRA
Location: Sydney/ Melbourne/ Brisbane (home-based)

ICON is seeking an experienced Lead Clinical Research Associate (LCRA) to support our long‑standing partnership with a global, research‑driven biopharmaceutical organisation recognised for its leadership in vaccine development and public health innovation. This is a high‑impact regional role supporting multiple vaccine studies across Australia.

If you are an experienced CRA with strong oversight capabilities, excellent communication skills, and a passion for driving operational excellence, this role offers the opportunity to step into a visible leadership position.

What You Will Be Doing:

  • Lead monitoring activities and provide oversight across APAC studies.
  • Present monitoring updates in study meetings and support project communication.
  • Coordinate and deliver study‑specific training for CRAs and sites.
  • Conduct monitoring and co‑monitoring visits to support quality and audit readiness.
  • Oversee visit scheduling, issue resolution, and monitoring plan compliance.
  • Review monitoring visit reports to ensure accuracy and timely completion.
  • Support study tools, systems access, documentation, and site/CRA queries.

Your Profile:

  • Bachelor's degree in life sciences, nursing, pharmacy, or a related field. Advanced degree preferred.
  • Extensive experience as a Senior CRA or Lead CRA, ideally within vaccine or infectious disease trials.
  • Strong understanding of ICH‑GCP, monitoring methodology and clinical trial operations.
  • Excellent communication and stakeholder engagement skills.
  • Demonstrated ability to coach, guide and support CRAs with performance and study delivery.
  • Strong organisational and problem‑solving capabilities.
  • Experience with CTMS, EDC, eTMF, IRT and clinical platforms is desirable.

#LI-KA1

#LI-Remote

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 maximize 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 site to read more about the benefits ICON offers.

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, color, 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 or submit a request here.

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.

Are you a current ICON Employee? Please click here to apply

Top Skills

Ctms
Edc
Etmf
Irt

ICON plc Sydney, New South Wales, AUS Office

Wallumedegal Country, 2 Lyon Park Road, North Ryde, Sydney, New South Wales, Australia, 2113

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