Expressions of Interest - Clinical Research Associate
- Full time (1 FTE) opportunities
- 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
We have a new and exciting opportunity for a Clinical Research Associate 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 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.
Duties and Key Responsibilities
- Assist with the identification and selection of investigators to undertake the study
- Conduct feasibility assessment
- Assist in the preparation of 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 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
- Basic 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
For more information, please see the Position Description here.
The closing date for applications is midnight, Friday 28th February 2023. We do, however, reserve the right to close this vacancy early if a suitable candidate is found.