Quality Assurance Officer- UK

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 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 specialists in Policy and SOP, Risk and Compliance, Governance, Data Analyst reporting to the Head of Quality Assurance to support research operations achieve and maintain excellence.

The Quality Assurance Officer will join the UK CORE Team and will work closely with the Innovative Clinical Trials Hub, the Project Operations team and researchers.

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.

This Quality Assurance Officer will be based in the TGI UK office in London.

The Role

The role of the Quality Assurance Officer is to support and assist the project operations team and researchers in their quality activities under the Quality Assurance Framework. The incumbent will liaise and work closely with the project operations team and researchers in the UK and the global Quality Assurance Team. The role will be responsible for, coordination, reporting and training on research quality processes within the UK office, supporting the global quality initiatives and the Head of Project Operations, UK.

The role will develop and prioritise area of work in for the UK office, in line with the Quality Assurance goals and objectives.

Reporting Relationships

The Quality Assurance Officer will report directly to the Head of Quality Assurance but will be working closely with the project operations team and Innovative Clinical Trials Hub in the UK on a day-to-day basis. For initiatives across TGI, working relationships and consultation with relevant staff in the other TGI regions may be necessary.

Duties and Key Responsibilities

Policies and SOPs

• Support the identification, development and review of Research Policies and SOPs, Work Instructions and related Associated Documents, working closely with the Global Policy and SOP officer to meet gaps, needs and requirements for the various research areas.
• Participate in working groups with project operations team and researchers on reviews or Policies and SOPs and ensure timelines are met.
• Provide feedback to the Policy and SOP Officer on any legislative or local changes required on any Research Policies, SOPs, Work Instructions and Associate Documents.
• Assist in the standardization of processes, where applicable, to have efficient workflow for project operations team and researchers through attending project meetings on a regular basis.
• Work closely with the Innovative Clinical Trials Hub Operations Manager to ensure processes related to innovative trials are reflected in SOPs and related Associated Documents. 

Risk Management and Compliance

• Work closely with the project operations team and researchers within the UK to support and enable staff to understand risk management, comply 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, Executive Director UK and Director, Global Project Operations.
• Support the risk management processes of risk review, risk reporting and escalations in the UK working closely with the project operations team and the Head of QA.
• Supervise and ensure the use of SPoT (in-house database) for all projects in the UK, and ensure the regular review of the data in SPoT are accurate, up-to-date and complete.
• Support/ the internal audit processes, in the UK working with the Head of QA and the other internal audit team members.
• Support the implementation of research compliance requirements as they apply in the UK and other relevant countries (e.g funders conditions, legislations, GDPR or GCP updates etc).

Training

• Support the development of QA training and where require maintaining compliance of Research Policies, SOPs and other annual mandatory training, such as risk management, quality initiatives and new compliance as the need arises.
• Ensure the training/ onboarding of new staff on QA and SPoT. Provision of refresher training and support for existing staff as required.
• Promote awareness and knowledge of quality initiatives under the Quality Assurance framework.
• Coordinate GCP training for all project operations staff and researchers in the UK, working with in-house GCP trainers.

CORE group support

• Support any Data Management and Statistics quality initiatives for project operations team and researchers.
• Manage the development of documentations, coordination of meetings and other CORE activities within the UK.
• Work closely with the Innovative Clinical Trial Hub, Project Operations Team and researchers on vendor, collaborator and partner management processes, as required.

As a Team Member:

• Engage with project operations staff and 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 TGI regions and globally on improvements for the UK office.
• 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.
• Promote and contribute to a safe, secure environment for staff and visitors.

Knowledge, Experience and Skills

• Relevant qualifications or equivalent experience in a related science or health care field.
• Knowledge of ICH-GCP, ethical and regulatory research requirements and research integrity principles.
• Have significant experience in clinical research operations or health care management.
• Experience in quality assurance, risk and compliance preferably in a clinical research or health care environment.
• Experience in incident or deviation management.
• Strong interpersonal verbal and written communication skills, including ability to work with team of all levels.
• Good computer knowledge and skills in using various tools, applications, and systems.
• Good time management and organisation skills.
• 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.
• Knowledge of or experience in internal audits and accreditation processes and standards.

Desirable

• Evidence of continuing education or professional development in research quality, continuous improvement or risk management

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.