Study Start Up Associate Ii

2 weeks ago

Sydney, Australia ICON plc Full time

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.

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

**The Role**
- Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF).
- Prepare, review and approve Global Master ICF templates for Sponsors, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors.
- Prepare, review and approve Country Master ICF templates inserting any required country elements, coordinate with Clinical Trial Manager and/or Site Activation Lead through to approval by Sponsors.
- Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF.
- Facilitate the indemnification process between the study sponsor and the site.
- Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).

**What You Need**
- A Bachelor’s degree in Science or related field.- 1.5-2 years independent start-up experience (Australia and New Zealand) in;- Study contracts review and budget negotiation or in related field such as where contract or legal document review.
- Performing initial submissions to ethics and regulatory.
- Negotiating site contracts and budgets (ideally within Oncology & Hematology).

**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.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

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.

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