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Cra Ii

2 weeks ago

Sydney, Australia ICON Plc Full time

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

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

CRA II / Senior CRA

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The role:

- Independently offer resolution strategies, documenting follow-up activities/outcomes.
- Facilitate collaborative CRA efforts to meet client objectives by organizing/managing special data collection efforts, USCRU meeting, present or set up task force, as directed by the client CPLs.
- Follow the Site Management / Ownership / Partnership model to monitor multiple Phase I, II & III clinical trial sites, across therapeutic areas.
- Independently schedule and prioritize workload to meet projected deadlines.
- Provide the following support as directed by the CPM or CRA Manager:

- Assist in field monitoring training;
- Conduct and observe site visits during training period; offering experienced counsel on issues related to SOPs, regulations and resolution tactics for site issues/concerns; assist
in interview and new program hire orientation process.
- Train/mentor new/junior CRAs in the conduct of all types of site visits as per client SOPs:
Potential Investigator Selection, Study Initiation, Monitoring and Close-out Visits.
- Manage and maintain home office, as appropriate, including reference study/site files to support monitoring responsibilities.
- Assist new CRAs in home office set-up and administrative activities.

You will need:

- Minimum 3 years of monitoring experience in phase I-III trials as a CRA
- Bachelor's degree in medicine, science, or equivalent
- Previous monitoring experience in medium-sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication
- Ability to work to tight deadlines
- Good command of written and spoken English
- Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

ICON is an equal opportunity and inclusive employer and 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.

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- Flexib