Clinical Research Associate (Trial Monitor) - Brazil

The George Institute for Global Health – UK Project Operations, CORE

CAREER STEP:Intermediate

REPORTING RELATIONSHIP:Project Manager

TEAM:UK Project Operations, CORE

EMPLOYMENT DURATION:2 years

TYPE OF EMPLOYMENT:0.8 FTE (4 days per week)

The George Institute for Global Health

We are a medical research institute affiliated with leading universities aiming to challenge the status quo in health care. With 700+ people around the world, and projects in over 40 countries, our Strategy 2030 is all about equity, resilience and impact – specifically, the impact of The George Institute’s activities on the health of millions of people, particularly those living in disadvantaged circumstances around the world.

Our strategy focuses on three key research priorities:

• Better Treatments: finding better treatments for the world’s biggest health problems
• Better Care: transforming primary health care to support better health for more people
• Healthier Societies: harnessing the power of communities, governments, and markets to improve health

Our innovative commercial enterprises help maximise our impact.

Here is a sample of the things we are doing to achieve our goal of having the greatest possible impact on global health:

• We are identifying better and safer treatments for our biggest killers like stroke, heart disease and high blood pressure;
• In many countries, our award winning FoodSwitch smartphone app is helping people make healthy food choices when shopping;
• In China, we ran a successful education and awareness program to reduce the amount of salt eaten by people by 25% each day
• In rural India, we have shown that mobile technology can help diagnose mental health, as well as help treat cardiovascular disease, and we’re looking at similar approaches to treating chronic diseases in Indonesia and China;
• Together with Aboriginal communities in NSW, Australia, we developed an innovative community led program to assist young Aboriginal drivers attain their license, now implemented in a dozen of locations;
• We are developing an affordable dialysis machine, with potential to save millions of lives each year and transform the way kidney disease is treated globally.

Context of the Role

The Project Operations team in UK works closely with our Research teams globally to ensure study aims are achieved. The team is primarily responsible for the set-up, conduct and overall delivery of projects across all research programs in The Institute, according to best practice guidelines and research budgets.

The Role

The Clinical Research Associate (CRA) is required to assist the Project Manager with various tasks associated with running clinical studies. Generally, the CRA performs all monitoring tasks required at study sites, including source data verification, safety reporting, drug accountability and the maintenance of study documentation. The CRA provides regular study updates and monitoring visit reports to the Project Manager and updates clinical study tracking systems as necessary.

The CRA may be required to travel frequently to Brazil including multiple day stays, as required to conduct on-site monitoring visits at investigative sites. This includes pre-study visits, site initiation visits, routine monitoring, and close-out visits, in accordance with the study protocol, Good Clinical Practice (GCP), and applicable regulatory requirements. The CRA must be adaptable to changing travel schedules, capable of managing time effectively while on the road, and committed to maintaining a high standard of data quality and site support during all visits.

The CRA is responsible for oversight and management of trial sites within Brazil and will be the main point of contact between the Brazilian sites and the trial team globally.

The CRA will also be required to assist with any other project related tasks, outside of Brazil.

Reporting Relationships

The CRA reports to Project Managers within the UK & Australian Project Operations teams. The CRA will also develop effective working relationships with the study site staff and the Australian and India Project Operations team.

Duties and Key Responsibilities

Study Design

• Assist with the identification and selection of investigators/sites to undertake the study
• Conduct feasibility assessments
• Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
• 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 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 study sites 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 study site research staff in the local management of the study where required.
• Collect and review essential documents from study sites and ensure they are complete at study close-out and appropriately stored/managed in-house

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.).
• Assist with global project requirements as requested, including contributing to project tasks deemed necessary by the project manager for all regions and countries, where the trial is being conducted.

As a Team Member

• Participate in activities 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.

Work, Health and Safety

• Comply with Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at the Institute;
• Promote and contribute to a safe, secure environment for staff and visitors.

Skills, Knowledge and Experience

Essential

• Academic Level (C1) written and spoken Brazilian Portuguese or fluent Brazilian Portuguese speaker
• Third-level qualifications in a related science or health care discipline
• Previous on-site monitoring experience in Brazil working on clinical projects, particularly drug trials, within an academic, CRO or pharmaceutical environment
• Experience with hospital and healthcare systems in Brazil
• Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.
• Sound understanding of medical terminology
• Working 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 varied stakeholders
• Strong problem-solving skills
• Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
• Ability and willingness to travel to Brazil and other regions as required by the needs of the project.

How to apply

Please provide a copy of your CV and an accompanying cover letter outlining why you think you'd be suitable for this role by clicking on the 'Apply' button above. The deadline for applications is midnight on Tuesday 10 March 2026. If you have any questions, please email recruitment@georgeinstitute.org.uk