Clinical Research Associate/ Senior Clinical Research Associate (Oncology)
Full Time (1.0 FTE)
No. of Vacancies:
3 Feb 2023 AEDT
Our mission is to improve the health of millions of people worldwide.
Full time/ Part Time (Flexible)
2 Year Fixed Term Contract
Hybrid working arrangements (combination of office and virtual work)
Make a leading contribution on a global scale
We have an opportunity for your career to make a difference!
We have a new and exciting opportunity for a Clinical Research Associate (CRA)/Senior Clinical Research Associate (SCRA) with experience in oncology to join our growing Academic Project Operations 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 CRA/SCRA 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.
Duties and Key Responsibilities
Assist with the identification and selection of investigators to undertake the study
Conduct feasibility assessment
Prepare 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
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
Assist Project Manager with other study related activities such as organising 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.).
As a Team Member
Participate in special projects to improve processes, tools, systems and organisation;
Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of The Institute’s Performance Management and Development Policy;
Demonstrate commitment to The Institute’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.
Skills, Knowledge and Experience
Tertiary qualifications in a related science or health care discipline
Previous CRA and 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
Good 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
The closing date for applications is 3rd February, 2023. We do reserve the right to close this vacancy early if a suitable candidate is found.
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
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 apply now!
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 work at 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