CRA II / Sr. CRA
About the role
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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.
Clinical Research Associate II (CRAII)/Senior CRA | Auckland, New Zealand
- Office based role in our Auckland City office; parking available
- Minimum 2 years independent site monitoring experience required
- Global CRO or Biotech/Pharma CRA industry experience preferred
The Role
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 I/ II 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 in 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.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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