Senior CRA
About the role
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Clinical Research Associate II (CRAII) / Senior CRA | Australia
- QLD, SA, VIC and NSW locations
- Immediate start for an experienced CRA
- Visa Sponsorship can be discussed
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
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. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.
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 II required
- Experience in phase I-III trials as a CRA, Oncology studies experience advantageous
- Knowledge of ICG 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 dependant on Covid-19 measures
- Possess current and valid working rights in Australia and preferably currently located in Australia preferred due to country and interstate border restrictions due to Covid-19
- Visa Sponsorship can be discussed for the right experienced candidate
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
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