Senior Clinical Research Associate

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

• Full Time Opportunity (5 days per week)
• Barangaroo Sydney CBD (Relocation to Randwick in September 2025)
• 24 Months Fixed Term Contract
• Hybrid working environment

Pro-Rata Salary Range of $94-100k Base Base (dependent on experience skills and capabilities) plus 11.5% Superannuation Smart Salary Packaging Benefit

The Senior Clinical Research Associate (SCRA) will support the Project Manager (PM) in the development and execution of various research projects (clinical and /or non-clinical trials) within the academic research programs of work priority based on business requirements at that time.

In addition to site management responsibilities the SCRA will support the PM on project management-related tasks allocated to them. The scope and level of responsibility is negotiated between the SCRA and PM. In conjunction with the PM the SCRA ensures that these research projects are performing according to the quality standards and deadlines required.

Key Responsibilities and Duties:

• Participate in the clinical trial feasibility assessment identify and selects investigators with the PM.
• Site management responsibilities:
  • Prepares and ensure the Human Research Ethics Committee (HREC) and relevant Regulatory submissions are completed within the project timelines.
  • Prepares/collects all documents needed prior to study initiation.
  • Conducts site initiation meetings to ensure compliance with SOPs and all study specific and regulatory requirements are met.
  • Develops and maintains a good working relationship with the Investigational site staff.
  • Management of the local study files including in-house and site file
  • Prepares organises and participates in Investigator meetings.

Site management

• Conduct on site and remote monitoring of participating centres to ensure:
  • Quality accuracy completion and timeliness of data entry.
  • Complete and efficient resolution of data issues and audit findings.
  • Adherence to the study protocol and study procedures manual.
  • Adherence to ICH-GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reported
• Complete all monitoring visit and progress reports accurately and within study specified timeframe.
• Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house.

Overseas regional co-ordinating centre management

• Manage and assist regional coordinating staff in the local management of the study where required.
• On occasion conduct co-monitoring with regional coordinating centre staff to ensure adherence to study protocol and study procedures manual
• Review and sign-off monitoring visit reports

Quality accuracy and completeness of data

• Ensure adherence to regulatory requirements e.g. ICH-GCP SOPs
• Assist project team to deliver clean accurate and verifiable data for final analyses
• File and archive clinical study data at end of project
• Ensure patient safety and adverse/serious adverse events are reported according to regulatory requirements
• Where applicable liaise with staff in Data Management and Statistics programs on project specific deliverables

Project Management Delegated Tasks:

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

• Developing tracking monitoring and filing systems
• Developing investigator payment tracking system
• Developing project-specific documents
• Investigational product management
• Manages project related logistics
• Case Report Form development
• Data management support of research projects.

All activities must be conducted in accordance with project specific documentation applicable SOPs ICH-GCP (if applicable) and applicable regulatory requirements.

For more information on this role please see our detailed Position Description here

Skills Knowledge and Experience/ Our Successful Candidate

• 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.
• 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
• Excellent 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.
• Experience working on oncology randomized controlled trials

Closing Date

The closing date for applications is 9th July 2025

We reserve the right to close this vacancy early if a suitable candidate is found

The unrestricted right to work in Australia is a requirement for this position. Candidates who require sponsorship will not be considered.

About the George

The George Institute for Global Health(The George) 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 beyondsingle diseases across the life courseto 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 people 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