Clinical Research Associate / Senior Clinical Research Associate
- Full time opportunity
- Flexible working arrangements available
- Respected global research organisation
- Make an impact on global health outcomes
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 'what we do' to read more about how we are addressing the world's biggest health problems.
We have a new and exciting opportunity for either a Clinical Research Associate or Senior Clinical Research Associate to join our growing Academic Project Operations team.
The Academic Project Operations (APO) team works closely with our research team to ensure study aims are achieved. The team is primarily responsible for the set-up, conduct and overall delivery of a projects across all research programs in TGI, according to best practice guidelines and research budgets.
The Clinical Research Associate (CRA) / Senior Clinical Research Associate (SCRA) will support the Project Manager (PM) in the development and execution of various research projects (clinical and 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 CRA / SCRA will support the PM on project management-related tasks allocated to them. The scope and level of responsibility is negotiated between the CRA / SCRA and PM. In conjunction with the PM, the CRA / SCRA ensures that these research projects are performing according to the quality standards and deadlines required.
Duties and Key Responsibilities
Clinical Trial Start-up Phase:
- 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
- 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:
- 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.
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 TGI’s Performance Management and Development Policy
- Demonstrate commitment to TGI’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
- 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.
This role is paid at $70 to $100k (base + super).