CRA II / Senior CRA

Clinical Research Associate II (CRAII)/Senior CRA | Auckland, New ZealandOffice based role in our Auckland City office; parking availableMinimum 2 years independent site monitoring experience requiredGlobal 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

Preferably possess current and valid working rights in New Zealand and currently located in Auckland preferred due to Covid-19.