Clinical Research Associate/ Senior Clinical Research Associate (Oncology)

Job No: GEORGE499
Location: Newtown, Australia

 

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
  • 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 (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

Study Design

  • 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

Study Execution

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

General

  • 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. 

Please see here for more information Position Description

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

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.

 

Apply Now

Privacy Acknowledgment

The George Institute for Global Health, together with its subsidiaries and associated companies worldwide (“The George Institute”, “we” and “our”) is committed to handling personal information (including health and other sensitive information) in accordance with applicable privacy laws, including the Australian Privacy Principles (“APPs”) set out in the Australian Privacy Act 1988 (Cth).

When you apply for a job at the Institute you will be asked to set up an account and apply for any of the jobs posted in the system. You may be asked to submit personal information including, but not limited to: a) your name; b) your address; c) your email address; d) your telephone number; e) and other personal and sensitive information.

Any personal information you submit to our recruitment system will be used to process your application and is retained in the database to match your skills against any future job opportunities. We may contact you about your current job application/s and any future job opportunities that match your criteria.

The George Institute works with people from diverse cultural and social backgrounds with varied life experiences, physical abilities and interests and we seek to employ people who reflect the great diversity of people. We may ask personal questions regarding your identity, which will be used to inform our Diversity, Inclusion and Belonging strategies with regards to recruitment. You may elect to not disclose this information.

I consent to The George Institute of Global Health to collect, use and disclose my personal information for the purpose of assessing and facilitating my application for employment.

Please see following link for more information on how the George Institute may collect and use your data: https://www.georgeinstitute.org/privacy-policy


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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 programs.