• 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

Apply now!

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.