Senior Project Officer / Senior Clinical Research Associate

• Full time (1 FTE)
• 2 year fixed term contract
• Respected global research organisation
• Make an impact on global health outcomes

The George Institute (‘TGI’) is 700+ people around the world, all focused on improving the health of millions of people worldwide. As 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 better treatments for the world’s biggest health problems
• Transform primary health care to support better health for more people
• Harness the power of communities, governments and markets to improve health

Our innovative commercial enterprises help maximise our impact.

An exciting opportunity exists for a Senior Project Officer / Senior Clinical Research Associate (SPO/SCRA) to join our growing organisation.

The SPO/ SCRA will support the Project Manager (PM) in the development and execution of various research projects (clinical and non-clinical trials) within the academic research programs. In addition to site management responsibilities, the successful candidate will also support the PM on project management-related tasks.

Key responsibilities of the role will include:

• Participation in clinical trial feasibility assessments
• Preparing, organising and participating in site initiation visits
• Planning and conducting site training
• Liaising directly with site staff and responding to queries
• Conducting on site and remote monitoring, including co-monitoring with regional coordinating centre staff
• Collecting and reviewing essential documents
• Managing and assisting regional coordinating staff in the local management of the study
• Ensuring adherence to ethical, regulatory & institute requirements e.g. ICH/GCP, SOPs
• Ensuring patient safety and adverse/serious adverse events are reported according to regulatory requirements
• Where applicable, liaising with staff in Data Management and Statistics Divisions on project specific deliverables and data archiving.

The SPO/SCRA may also be asked to support the PM on project management-related tasks including:

• Development of tracking, monitoring and filing systems
• Development of project-specific documents (e.g. Operation Manuals, Monitoring Plans and Case Report Form)
• Ensures appropriate study drug (investigational product) management processes are in place

Our ideal candidate will possess:

• Tertiary qualifications in a related science or health care discipline
• At least 2 years of monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment
• Excellent knowledge of ICH/ GCP guidelines, and are able to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions
• Understanding of medical terminology
• 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.

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.

Everyone is encouraged to apply, including Aboriginal and Torres Strait Islander people, people from culturally and linguistically diverse backgrounds, people with a disability, LGBTIQ people and mature-aged adults.