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Cra Ii

3 weeks ago

Sydney, Australia Icon plc Full time

Clinical Research Associate (CRA) II/ Senior CRA | Sydney, NSW

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 I/ 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- Preferably possess current and valid working rights in Australia and currently located in Australia preferred due to country and interstate border restrictions due to Covid-19

Are you a current ICON Employee? Please click here to apply:
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