Senior Quality Assurance Associate

Our mission is to improve the health of millions of people worldwide.

• Full time Position
• Location - Hyderabad OR New Delhi, India, depending on best candidate 
• Fixed Term – 1 Year

We have an opportunity for your career to make a difference!  We have a new and exciting opportunity for a Senior Quality Assurance Associate to join our organization.

 How to apply:
Interested candidates should send their 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 17 March 2024

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.

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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 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.
• Ensure direct reports understand and comply with safe work practice and procedures.

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.

For more details, please see the Position Description for this role.

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. 

About the George Institute

We are a medical and health 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 2025 is all about 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

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