Our mission is to improve the health of millions of people worldwide.

• Full-time
• 24 Month Contract
• Hybrid working arrangements (combination of office and virtual work)
• Make a leading contribution on a global scale
• Fantastic culture

We have an opportunity for your career to make a difference! We have a new and exciting opportunity for a Clinical Research Associate/Senior Clinical Research Associate to join our growing Academic Project Operations team.

The Opportunity

We are looking for a Clinical Research Associate/Senior Clinical Research Associate who will be responsible for performing all monitoring tasks required at study sites, including source data verification, safety reporting, drug accountability and the maintenance of study documentation. The S/CRA provides regular study updates and monitoring visit reports to the project manager and updates clinical study tracking systems as necessary.

Duties and Key Responsibilities:

As a S/CRA you will have the chance to get involved in all phases of a trial from start-up to close-out, including:

• Participate in the clinical trial feasibility assessment, identify and selects investigators with the PM.
• Contribute to and develop trial related documents such as protocols, consent forms, manuals and Case Report Forms.
• Prepares, organises and participates in, Investigator meetings.
• Conduct on site and remote monitoring of participating centres.
• Complete all monitoring visit and progress reports accurately and within study specified timeframe.
• Manage and assist regional coordinating staff in the local management of the study where required.
• Ensure adherence to regulatory requirements e.g. ICH-GCP, SOPs.
• Assist project team to deliver clean, accurate and verifiable data for final analyses.
• The CRA may be asked to support the PM on project management-related tasks.

Our successful candidate has/is:

• Tertiary qualifications in a related science or health care discipline.
• At least 1-2 years of monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment.
• Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.
• Understanding of medical terminology, 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.
• Based in Sydney and ability and willingness to travel.
• Desirable experience working on adaptive platform trial design and evidenced scientific writing and document development skills.

For a more details, please see the attached Position Description for this role. 

About the George

The George Institute  (TGI) is 700+ employees around the world and projects in over 40 countries all focused on improving the health of millions of people worldwide.

As a medical research institute affiliated with leading universities, we are challenging the status quo in healthcare to:

• Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery
• Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale
• Develop low-cost, innovative solutions to global unmet needs
• Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship

We pride ourselves with our 6 core values: excellence, integrity, can-do approach, creativity, impact, and humanitarian commitment.

Please visit our website for more on The George: Home | The George Institute for Global Health  

Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work. 

We value workplace diversity and encourage applications from people living with disability; women; Aboriginal and Torres Strait Islander people; people who identify as LGBTIQ+; mature-aged adults and those from culturally and linguistically diverse backgrounds.

Why 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.

Take advantage of our rewards you may enjoy as part of The George team.

• Generous salary packaging benefits increasing your take home pay
• Learning and career development opportunities
• Extra leave days including extended Christmas break and study leave
• YourFlex arrangements e.g. start/finish times, purchase leave, location
• A global, diverse, inclusive team committed to making impact