Quality Assurance Officer

Job overview

Reporting to the JRO Quality Assurance Manager, a talented individual is sought to provide support in further development and delivery of the quality management and assurance system for the UCLH and UCL research portfolio within the JRO (Joint Research Office).

A proactive self-starter with excellent organisation and analytical skills with a proven understanding of data systems. You will be responsible for maintaining systems for the tracking and analysis of research incidents reported via Trust or UCL platforms. These systems include but are not limited to recording each incident, tracker maintenance to include analysis of trends and preparation of reports as required. You will provide guidance and advice in respect of reporting research incidents together with specific incident advice. You will be included in our audit program to audit processes, systems and the non-commercially sponsored research studies within the JRO portfolio.

You should demonstrate a pragmatic approach with proven excellent communication skills. You will be expected to communicate effectively with senior clinical researchers, academic researchers, colleagues from within the designated research units across the NHS Trust and UCL.

The post holder will be required to maintain a good working relationship and a high level of customer service with the teams within the JRO, Trust, University as well as external stakeholders.

Main duties of the job

• Liaise with investigators, UCLH and UCL research divisions and units to offer support and guidance relating to research incident reporting, process, guidance and SOPs.  2.    Liaise with external stakeholders to provide quality advice and guidance on incident management, regulatory issues and research management in the implementation of research policy, e.g. implementation of the GCP regulations, HRA, Data Protection Act, UK GDPR, Human Tissue Act, Material Transfer, SOP’s and Policies relating to the JRO research portfolio. 3.    Prepare reports for dissemination at regular Quality and Safety meetings to reflect reported research incidents, outcomes and analysis.  4.    To report on trends within reported research incidents and provide analysis. 5.    Ensure appropriate corrective and preventative action plans (CAPA) are recorded within trackers and JRO Quality Management System QMS 6.    Maintain the online Quality Management System (QMS) of SOPs, associated documents and file notes. Track the compliance to the QMS of SOPs of the JRO teams using online logs.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

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