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

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The George Institute - Clinical Research Associate - Project Management (2-3 yrs) Premium

Anywhere in India/Multiple Locations/Delhi/Hyderabad Job Code: 23755

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 Research Associate (CRA) will work on trials testing new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Reporting Relationships : Directly reports to the Project Manager

Duties and Key Responsibilities :

The Clinical Research Associate would be expected to :

- Assist in the development of trial related documents including but not limited to the protocol, investigator's brochure, patient information documents and care report forms.

- Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.

- Assist in regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.

- Assess the suitability of facilities to use as the clinical trial site.

- Assist in the selection of an investigator who will be responsible for conducting the trial at the trial site.

- Liaise with doctors, consultants or investigators on conducting the trial.

- Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)

- Train the site staff to trial-specific standards.

- Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues

- Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)

- Collect completed CRFs from hospitals and general practices

- Write visit reports and file and collate trial documentation and reports

- Meet with team members to discuss on-going trials, results and any trends or adverse events

- Ensure all unused trial supplies are accounted for

- Close down trial sites on completion of the trial

- Archive study documentation and correspondence

- Prepare final reports for sponsors, regulatory authorities, and ethics committees

As a Team Member :

- Participate in team meetings and activities relating to the TRACK trial 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: Bachelors in life sciences, medical sciences or nursing with masters degree in clinical research.

- Experience of at least 2 years as a clinical research coordinator or 1 year as a clinical research associate.

- Demonstrated experience in working with electronic data capture tools such as REDCap, OpenClinica, Zelta etc.

- Willingness to travel to conduct frequent site monitoring visits.

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

- Strong problem solving, analytical skills, and proven strategic thinking.

- Demonstrated resourcefulness, with ability to influence others to achieve common goals.

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

- 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 organisational priorities and ambiguous environments.

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

- Well organised 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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