Job Description

 Job Description

JOB TITLE

Senior Quality Assurance Associate

REPORTING TO

Head CORE India

LOCATION

Hyderabad OR New Delhi, India, depending on best candidate

OPEN ENDED /

FIXED TERM (Duration)

Fixed term (1 years)

FULLTIME EQUIVALENT

1.0

JOB FAMILY

Professional

CAREER STEP

Intermediate

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

The Centre for Operational and Research Excellence (CORE) is responsible for delivery and implementation of the Institute’s research strategy globally. CORE consists of three groups: Research Strategy and Services, Global Project Operations and Statistics. 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 Global Quality Assurance Team consist of experts and specialist in Policy and SOP, Risk and Compliance, Governance, Data Analyst reporting to the Quality Assurance Manager to support research operations achieve and maintain excellence.

The role of the Senior Quality Assurance Associate is to support and enable the research project operations quality activities under the Quality Assurance Framework. The role will be a liaison role working closely with the research project operations staff and researchers in each region and the global Quality Assurance Team. The role will be responsible for the implementation, coordination, reporting and training on research quality processes within the region.

 This role will be based at The George Institute Hyderabad or New Delhi Office, depending on the best candidate.

The role will also be developing KPIs for the region with the Head of CORE India, in line with the Quality Assurance objectives.

Reporting Relationships

The Senior Quality Assurance Associate will report to the Head of CORE India and Global Quality Assurance Manager in Australia.  They will establish and manage regular working relationships with the regional and global research project operations staff and Quality Assurance Team members.

Duties and Key Responsibilities

Policies and SOPs

Support the identification, development and review of Research Policies and SOPs, Work Instructions and related Associate Documents, working closely with the Policy and SOP officer to meet regional gaps, needs and requirements for the various research areas. .

Liaise with the researchers and project operations teams to ensure the Research Policies, SOPs, Work Instructions and Associate Documents are relevant for use.

Assist in the standardization of processes, where applicable, to have efficient work flow for research staff.

Risk Management and Compliance

Work closely with the researchers and project operation teams within the region to support and enable staff to understand risk management, be in compliance with changes and assist solutions and improvements.

Fulfil the role of the Research Integrity Officer (RIO) in any complaints, working with the Head of Quality Assurance, Head of CORE and Director of CORE. 

Support the risk management processes of risk review, risk reporting and escalations in the region working closely with the Risk and Compliance Officer. 

Coordinate and ensure the use of SPoT (in-house database ) for all projects, working closely with the research project operations teams, to maintain regular review that the data is accurate, up-to-date and complete.

Assist in the administration and coordination of the internal audit processes, in the region working with the internal audit team.

Support the implementation of research compliance requirements as they apply in the region (e.g funders conditions, legislations, GDPR or GCP updates etc).

Training

Provide training to maintain compliance of Research Policies, SOPs and other annual mandatory training.

Provide training on the use of the SPoT database modules in the region to new staff and refreshers for exiting staff as required.

Assist and/or provide training on risk management, quality initiatives and new compliance as the need arises, working with CORE Quality Assurance Team 

Promote awareness and knowledge of quality initiatives under the Quality Assurance framework. 

Support capacity building training/courses in the 

Ensure compliance with GCP for all research project operations staff, working with in-house GCP trainers to coordination, administration and maintain training records.

CORE group support

Support Data Management and Statistics quality requirements within the research operations activities.

Support development of documentations, coordination of meetings and other CORE activities as required from time to time.

Support and be the liaison for findings relating to research project operations project review process to inform Internal Audit activities.

Provide support on vendor, collaborator and partner management processes working closely with the Governance Manager

As a Team Member:

Engage with researchers and be the point of contact and liaison for quality assurance processes, issues or concerns.

Work with and support the various CORE areas and create a collaborative culture .

Participate in special projects with the Quality Assurance Team across the regions and globally on regional improvements.

Collaborate with others and provide advice, where applicable.

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.

Skills, Knowledge and Experience

Postgraduate qualifications in a health-related or science field.

Have at least 3-4 years’ experience in research operations activities.

Experience and working knowledge in clinical trials and community based public health research project essential.

Some experience in quality assurance preferably in academic research environment.

Strong interpersonal verbal and written communication skills, including ability to work with staff of all levels.

Good computer knowledge and skills in using various tools, applications and systems.

Worked in quality assurance, risk management and/or compliance areas. 

Knowledge of ICH-GCP, ethical and regulatory research requirements and research integrity principles.

Good time management and skills in being organised.

A team player with strong problem solving and analytical skills.

Ability to be flexible and adaptable in the face of changing priorities and ambiguous environments.

Desirable

Graduate Certificate in any area of quality controls or continuous improvements.

Knowledge or worked with accreditation processes and standards.

How to apply:

Interested candidates should send a cover letter explaining their fit to this position, along with a copy of recent resume with full contact details, current and expected CTC/salary. Clearly mentioning the job title “Senior Quality Assurance Associate” in the subject line to hrindia@georgeinstitute.org.in by the 17th of March, 2024

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.

About Company

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