Cra Ii/scra

2 days ago

Sydney, Australia Icon plc Full time

ICON plc is a world-leading healthcare intelligence and clinical research oransation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

**CRA II/SCRA**
- Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
- Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
- Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
- Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
- Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner
- Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report
- Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by a Project Manager
- Assume additional responsibilities as directed by Project Manager (PM)
- Dependent on level of experience you may assist in training and mentoring less expert CRA's and/or lead CRA's working on international projects

**What you need**
- Minimum 2-3 years experience as a CRA II or SCRA required.
- Experience in phase I-III trials as a CRA, Oncology studies experience advantageous
- Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
- You will possess excellent written and verbal communication in English
- Ability to produce accurate work to tight deadlines within a pressurized environment
- You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license; this is dependent on Covid-19 measures
- Preferably possess current and valid working rights in New Zealand and currently located in Auckland preferred due to Covid-19.

**Benefits of Working at ICON**

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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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