Clinical Research Associate II (CRAII)/ Senior CRA

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

At ICON, it's our people that set us apart.

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 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
  
• Current and valid working rights in New Zealand and currently located in Auckland preferred due to Covid-19.
  

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