17/01 Babita Lukhar
HR Officer at The Gorge Institute for Global Health

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The George Institute - Clinical Trial Assistant - Epidemiological Studies (1-2 yrs)

Delhi/Hyderabad Job Code: 23756

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.

Our experts are among the most cited globally, bestowed accolades for excellence and innovation, and regularly participate in policy fora. Our research is published in leading academic journals, referenced in policy documents, and recognised for its excellence, innovation and impact. We are designated a WHO Collaborating Centre (WHO CC) for Injury Prevention & Trauma Care, and a WHO CC for Population Salt Reduction. Since 1999, we have raised more than $1 billion for research and produced over 10,000 peer-reviewed publications and other academic outputs.

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.

The George Institute India :

The George Institute, a wholly owned legal not-for-profit Indian research institute, has been conducting research related activities in India since 2002. The George Institute India's mission mirrors that of the parent organization, namely the discovery and implementation of solutions to chronic and disabling health problems through research, policy development and capacity building.

A number of large-scale projects in population, health systems and clinical research, funded by a diverse group of sponsors, both public and private, are conducted in India. The George Institute India comprises two distinct operating groups: Research and Development, and Infrastructure and Resources. It has two separate offices - in Hyderabad and New Delhi, where the research staff and senior management are based.

Context and Role :

Non-communicable diseases (NCDs) cause over 70% of all deaths worldwide each year. 85% of premature deaths due to NCDs are in low- and middle-income countries. The George Institute is focused on finding better treatments for the world's biggest health problems including renal and cardiovascular diseases.

We are conducting large-scale clinical trials, often across multiple countries and clinical sites, and developing new medicine and technology solutions to prevent and treat common chronic and critical conditions with a global perspective.

Our work is transforming practice and improving health outcomes worldwide. A Clinical Trial Assistant will work on trials testing new and existing drugs and will typically be involved in coordination and administration across all stages of a clinical trial from start-up to close-out.

Reporting Relationships : Directly reports to Operations Lead.

Duties and Key Responsibilities :

The Clinical Trial Assistance would be expected to :

- Assist in the coordination and administration of clinical trials from the start-up to execution and closeout.

- Schedule meetings with multiple stakeholders and record and circulate the minutes of the meetings with relevant action points.

- Collect, assist in preparation, review, and track documents for the IEC application process.

- Assist in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

- Serve as the local administrative main contact and works closely with the CRAs for the duration of the study.

- Operationalise the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.

- Ensure essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF and ensure audit readiness.

- Ensure that all study documents are ready for final archiving and completion of the local part of the eTMF and supports the CRA in the close-out activities for the ISF.

- Contribute to the production and maintenance of study documents, ensuring template and version compliance.

As a Team Member :

- Participate in team meetings and activities relating to the ongoing clinical trials and own work area

- 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 GI's 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 GI's Work Health and Safety Policy and related procedures, and similar policies which apply when visiting the premises of affiliates and collaborating sites.

- Promote and contribute to a safe, secure environment for staff and visitors.

Skills, Knowledge and Experience :

- Qualifications: Qualification in life sciences, medical sciences or nursing with.

- Experience of at least 1 year in clinical trial coordination.

- Demonstrated capability to produce outcomes and achieve objectives within agreed time periods.

- Excellent interpersonal skills with high level of proficiency in English and the ability to work well autonomously.

- Strong written and verbal communication.

- Excellent team-work skills, with demonstrated ability to collaborate in small teams and with a wide range of varying stakeholders.

- Ability to demonstrate flexibility and to be adaptable to changing organizational priorities and ambiguous environments.

- Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs.

- Well organized and efficient, with the capacity to work under pressure.

About :

Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.

Everyone is encouraged to apply, including people from culturally and linguistically diverse backgrounds, people with a disability, people of all gender identities and sexual orientations, and mature-aged adults.

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