Clinical Research Associate

Job No: GEORGE68
Location: Newtown, Australia

  • Full time opportunity - Part time will be considered
  • Respected global research organisation
  • Make an impact on global health outcomes

‘The George’ is 600+ people globally focused on improving the health of millions of people. A medical research institute affiliated with leading universities and with projects in approximately 50 countries, we are challenging the status quo in healthcare to find the best ways to prevent and treat chronic disease and injury, and to influence policy and practice worldwide.

A unique opportunity exists for a Clinical Research Associate (CRA) to join our growing organisation. The Clinical Research Associate performs all monitoring tasks required at study sites, including source data verification, safety reporting, drug accountability and the maintenance of study documentation. 

Key responsibilities of the role will include:

Study Design

  • Assist with the identification and selection of investigators to undertake the study
  • Conduct feasibility assessment
  • Assist in the preparation of documentation for ethics submission
  • Create, organise and collate documents required by the project team prior to the start of the study (e.g. protocols, questionnaires, feasibility, confidentiality agreements, etc.)
  • Assist in the development of appropriate monitoring tools
  • Organise and participate in investigator meetings
  • Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
  • Prepare for, plan, organise and conduct site initiation visits
  • Collect and review essential documents from study sites
  • Motivate and train investigators
Study Execution
  • Perform study monitoring by visit, email and telephone to the participating centres to ensure:
    • Data quality, accuracy, completeness and timeliness of data completion
    • Complete and efficient resolution of data queries
    • Adherence to the study protocol and study procedures manual
    • Adherence to ICH/GCP and other guidelines and requirements as relevant to this trial
  • Complete monitoring visit reports accurately and within the predetermined timeframe
  • Coordinate distribution, tracking, handling and destruction of study supplies per site
  • Assist participating centre research staff in the local management of the study where required

General

  • Assist Project Manager with other study related activities such as organizing study meetings and scheduling travel, producing agendas and minutes for study-related meetings, responding to protocol and data collection enquiries, maintaining study documentation, assisting in the preparation of budgetary and administrative documents and other tasks as required
  • Manage effective communication with the key stakeholders (including the Study Management Committee, Principal Investigators, Research Coordinators, etc.)

Desired Skills and Experience

Our ideal candidate will possess:

  • Tertiary qualifications in a related science or health care discipline with experience in the Intensive Care environment desirable
  • At least 1 year clinical research experience (particularly within ICU research setting) highly desirable
  • Previous monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment highly desirable
  • Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions
  • Basic understanding of medical terminology
  • Knowledge of ICH/ GCP guidelines
  • Understanding of confidentiality and privacy laws and all guidelines relevant to medical research
  • Excellent skills in MS Office applications including Excel and Word
  • Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
  • Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
  • Ability and willingness to travel

We offer a flexible and inclusive work culture with excellent staff benefits including, salary packaging arrangements and sound learning opportunities.

The George Institute is an equal employment opportunity employer committed to equity, diversity and social inclusion. Applications are encouraged from people with a disability; women; Aboriginal and Torres Strait Islander people; people who identify as LGBTIQ; mature-aged adults and those from culturally and linguistically diverse backgrounds.

Privacy Acknowledgment

The George Institute for Global Health, together with its subsidiaries and associated companies worldwide (“The George Institute”, “we” and “our”) is committed to handling personal information (including health and other sensitive information) in accordance with applicable privacy laws, including the Australian Privacy Principles (“APPs”) set out in the Australian Privacy Act 1988 (Cth).

When you apply for a job at the Institute you will be asked to set up an account and apply for any of the jobs posted in the system. You may be asked to submit personal information including, but not limited to: a) your name; b) your address; c) your email address; d) your telephone number; e) and other personal and sensitive information.

Any personal information you submit to our recruitment system will be used to process your application and is retained in the database to match your skills against any future job opportunities. We may contact you about your current job application/s and any future job opportunities that match your criteria.

The George Institute works with people from diverse cultural and social backgrounds with varied life experiences, physical abilities and interests and we seek to employ people who reflect the great diversity of people. We may ask personal questions regarding your identity, which will be used to inform our Diversity, Inclusion and Belonging strategies with regards to recruitment. You may elect to not disclose this information.

I consent to The George Institute of Global Health to collect, use and disclose my personal information for the purpose of assessing and facilitating my application for employment.

Please see following link for more information on how the George Institute may collect and use your data: https://www.georgeinstitute.org/privacy-policy


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Why work at the George?

We are committed to attracting, developing, rewarding and retaining the best people in their fields to conduct and support our innovative and highest quality research programs.