Clinical Research Associate - Spanish Speaking

Context of the Role 

The Centre for Operational and Research Excellence (CORE) is responsible for delivery and implementation of the Institute’s research strategy globally. CORE consists of four groups: Research Strategy and Services, Global Project Operations, Biostatistics / Data Science and Quality Assurance. CORE’s aim is to provide high quality expertise as well as centralised and integrated research management systems and services to ensure effective and high-quality delivery of each TGI’s research program from its design to its outputs.

The Project Operations (PO) team works closely with our Researchers to ensure studies and projects are delivered.  

The Role

The Clinical Research Associate (CRA) is required to assist the Project Manager with various tasks associated with running a large-scale clinical trial. Generally, the Clinical Research Associate 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 Spanish speaking role will require the ability to communicate with the sites in Spanish but liaise with the Project Manager in English. 

The CRA will join the Project Operations team and will work closely with the Innovative Clinical Trials Hub. 

The Innovative Clinical Trials Hub is a new global initiative within Project Operations, aiming to create a team of experts to support the design, delivery, and analysis of innovative clinical trials. These will include platform, adaptive trials, decentralized trials and utilize novel methods of identifying & recruiting participants, delivering trial interventions, and conducting analyses. 

Reporting Relationships

The Clinical Research Associate reports to a Project Manager within the Project Operations team. The Clinical Research Associate will also develop effective working relationships with the programs study site staff, especially in Spanish speaking regions. 

Duties and Key Responsibilities

Study Design

• Assist with the identification and selection of investigators to undertake the study
• Conduct feasibility assessments
• 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. 

Study Execution

• Perform study monitoring by visit, email and telephone to the participating centres, in Spanish and English 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 Spanish speaking 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.

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

• Tertiary qualifications in a related science or health care discipline
• Excellent fluency in written and spoken Spanish – academic level
• 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.
• 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 varying 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.

About The George Institute

The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide, particularly underserved populations, by challenging the status quo and using innovative approaches to prevent and treat the world’s biggest killers: non-communicable diseases and injury.

With offices in Australia, China, India and the UK, our 700+ people support 245+ active projects and clinical trials across 50+ countries, with 400+ more staff across our social enterprises. We focus on the global health challenges that cause the greatest loss of life, the greatest impairment of life quality and the most substantial economic burden, particularly in resource-poor settings.

Together with our academic partners, UNSW Sydney in Australia, Manipal Academy of Higher Education in India and Imperial College London in the United Kingdom, we work with a global network of collaborators, undertaking clinical, population and health systems research.

What we do:

• 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

For more information about The George Institute, visit www.georgeinstitute.org.