Clinical Research Associate - Critical Care
- Full time (1 FTE) opportunity
- 2 year, fixed term contract
- Hybrid working arrangements available, with a combination of office and virtual work
- Respected global research organisation
- Make an impact on global health outcomes
- Fantastic culture
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.
Please visit our website www.thegeorgeinstitute.org.au to read more about how we are addressing the world's biggest health problems.
We have a new and exciting opportunity for a Clinical Research Associate to join our growing Academic Project Operations team, in particular working in our Critical Care team.
The Academic Project Operations (APO) team works closely with the research team to ensure study aims are achieved. The APO team is primarily responsible for the set-up, conduct and overall delivery of projects across all research programs in TGI, in accordance with best practice guidelines and research budgets.
The Critical Care Program (CC) has established an international track record in programs of Critical Care research including high-quality, large-scale, randomized controlled trials, cohort and observational studies.
The programs focus on all aspects of the management of critically ill patients from the pre-hospital phase through hospital management, specifically in Intensive Care, short-term recovery, rehabilitation and long term health-related functional recovery and quality of life.
Some of the projects in the CC Program include large-scale randomised-controlled trials on fluid resuscitation (SAFE, SAFE-TBI, CHEST, PLUS), glycaemic control (NICE-SUGAR), dose of dialysis (RENAL), and Sepsis (ADRENAL, SuDDICU), plus other programs such as thermoregulation (in patients with traumatic brain injury, sepsis and cardiac arrest), translation of research into practice and health economic evaluation.
The Clinical Research Associate (CRA) role will work closely with the Project Manager (PM) in the development and execution of one or more clinical research projects within the academic research programs of work. As a member of the project team, the CRA is expected to provide support in aspects of the project delivery.
Project allocation is dependent upon research priorities and business need and may be across more than one therapeutic area.
Duties and Key Responsibilities
Clinical Trial Start-up Phase:
- Attend relevant project specific meetings
- Work with PM to conduct the clinical trial feasibility assessment, identify, and selects investigators
- Work with PM in developing project-specific documents
- Prepare ethics applications and regulatory submissions as required
- Site set up, initiation & management responsibilities
- Prepares, organises and participates in, Investigator meetings.
- Contribute towards the study development
- Conduct and report on, on-site and / or remote monitoring of participating centres to ensure:
- Stakeholder relationships & engagement with site staff
- Essential document management.
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:
- Developing project systems e.g. tracking, monitoring and filing systems, site payments
- 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.
We’re looking for someone to thrive in an autonomous, busy role, where there are lots of opportunities to be creative and use initiative to solve problems.
The key skills and experience the CRA will bring include:
- Tertiary qualifications in a related science or health care discipline
- 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 to prioritise
- Ability and willingness to travel.
- Qualification and/or experience in Intensive Care/ Critical Care clinical setting
- Monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment
For more information, please see the Position Description here.
The closing date for applications is Friday 28th October, 2022.
We do reserve the right to close this vacancy early if a suitable candidate is found.