Clinical Research Associate x2

• 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

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 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. As a senior member of the project team, the SCRA is expected to provide leadership in aspects of the project delivery and in team support.

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:

• Co-lead the clinical trial feasibility assessment, identify, and selects investigators with the PM
• 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.

Site management:

• Conduct and report on, on-site and / or remote monitoring of participating centres to ensure:
  • Stakeholder relationships & engagement with site staff
  • Essential document management.

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 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.
• Deputise for PM when required.

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 people who 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
• 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 to prioritise
• Ability and willingness to travel.

Desirable

• Experience in oncology, neurology and / or renal clinical trials

For more information, please see the Position Description here.

The closing date for applications is midnight, Friday 26th August, 2022. We do, however, reserve the right to close this vacancy early if a suitable candidate is found.