Guy's and St Thomas' NHS Foundation Trust

Quality Assurance Associate

Information:

This job is now closed

Job summary

Quality Assurance Associate

Are you an enthusiastic, dynamic, self-motivated clinical research professional looking for a new and exciting challenge? Why not consider contributing to our ground-breaking research by joining the National Institute for Health Research (NIHR) Clinical Research Facility (CRF) at Guy's and St. Thomas' NHS Foundation Trust?

An exciting opportunity has arisen for a highly motivated Quality Assurance Associate with proven clinical research experience who is capable of driving and maintaining the quality of clinical research delivered within our CRF.

Closing Date: 24 May 2022 at Midnight

Interview Date: 01 June 2022

Main duties of the job

In this role you will support the R&D/BRC Quality Assurance Manager and Deputy R&D / BRC Quality Assurance Manager with the implementation, maintenance and development of the CRF Quality Management System to assure that clinical research is completed in accordance with prevailing legislative and best practice requirements, including Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations (as amended from time to time), the Human Tissue Act 2004, the General Data Protection Regulation (as implemented in the Data Protection Act 2018), MHRA Phase I Accreditation Requirements, Good Manufacturing Practice, Good Clinical Laboratory Practice, the UK Policy Framework for Health and Social Care Research 2017 and the Mental Capacity Act 2005.

You will play a key role in enabling the efficient and effective day to day operation of the CRF and work to implement Trust and CRF policy intolocal working practices to ensure compliance with all relevant regulatory standards and good practice guidelines at all times.

You will provide assurance that all Phase I research conducted in the CRF is delivered to a consistent standard of quality in accordance with the requirements of the MHRA Phase I Accreditation, particularly those studies involving dose escalation. Hence you will develop and maintain a robust understanding of MHRA Phase I accreditation requirements as they apply to research conducted within the Phase I Accredited Unit at Guy's CRF.

About us

The National Institute of Health Research (NIHR) Clinical Research Facility (CRF) for Experimental Medicine at Guy's and St Thomas' NHS Foundation Trust provides state of the art facilitates and world-leading expertise to support the NHS, universities and industry in conducting ground breaking experimental medicine studies.

With MHRA Phase I accreditation for our Guy's CRF unit, we are uniquely placed to deliver Phase I commercial and non-commercial patient focused studies. Our CRF is the only one in the UK with embedded Advanced Therapies Manufacturing (GMP) and immune monitoring platforms.

In this role you will be working within the highly regulated environment of Phase I clinical research helping to ensure we maintain our accreditation status. You will be basedprimarily within the adult CRF units, in particular the Phase I accredited unit at Guy's Hospital; however you will be expected to engage with and maintain a visible presence across all units of the CRF and act as a point of contact for escalation of quality queries.

Comprehensive induction, orientation and training will be provided for successful candidates. We will also ensure that you have tailored, individualpersonal development plans with support for further training.

Details

Date posted

13 May 2022

Pay scheme

Agenda for change

Band

Band 6

Salary

£38,768 to £46,124 a year p.a. inclusive of HCA

Contract

Permanent

Working pattern

Full-time

Reference number

196-BRC1769

Job locations

Clinical Research facility 15F Tower Wing Guy's Hospital

Great Maze Pond

London

SE1 9RT


Job description

Job responsibilities

Quality Assurance in the Clinical Research Facilities

  • Maintain the systems which provide assurance of the quality of clinical research activity undertaken within the four arms of the CRF and wider BRC as required.
  • Be responsible for the management of the CRF system for data quality control checks required to maintain the MHRA Phase I Accrediation, escalating issues to CRF Management as necessary and facilitating oversight.
  • Liaise with research teams to ensure time critical QC checks are performed ahead of Safety Review Committee meetings and any discrepancies addressed.
  • Plan and perform QC checks to a high degree of accuracy, reconciling data held in electronic data capture systems (eCRFs) with source data held in electronic health records for example EPR, enoting and CIS Mosaiq for selected studies running in the CRF and out in the wider R&D directorate (as required).
  • Ensure that paper-based and electronic documentation is maintained to the high standards expected upon audit and regulatory inspection for relevant CRF-managed studies and support colleagues from external research teams to do the same.
  • Recognise and respond to research governance and quality issues that might arise during quality control checks.
  • Develop tools to permit review of results of quality control checks and develop system metrics to allow assessment of compliance with quality standards.
  • Prepare and deliver practical training on specific quality assurance processes to allow staff across R&D to engage in and support data quality control as required and act as a Subject Matter Expert for data quality control.
  • Act as a Lead User for Q-Pulse, supporting the Deputy R&D / QA Manager to manage staff profiles and access, and document distribution within the system. Assist in the generation and management of Q-Pulse reports and the implementation of software updates.
  • Support the Deputy R&D / QA Manager in operating help facilities via the CRFQuality in box.
  • Participate in the hosting of regulatory inspections and audits as required.
  • Promote a Quality Culture among CRF staff, users and the wider clinical research community.
  • Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
  • Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and /or SOPs, responding appropriately and escalating action as required.
  • Participate in Good Clinical Practice audits of research studies running in the CRF and on occasion within the wider Trust as part of the audit programme implemented by the R&D/BRC Quality Assurance Manager.

MHRA Phase I Accreditation

  • Develop and maintain expert knowledge of the MHRA Phase I accreditation requirements and associated guidelines, and how they apply in the CRF operational context.
  • Work closely with high-level stakeholders across the CRF and within research teams to implement the plan for maintenance of Phase I accreditation under the supervision of the R&D/BRC and Deputy R&D /BRC QA Manager.
  • Recognise and escalate any risks to the CRF Phase I accreditation.

Information and Data Management

  • The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and the CRF specific software such as Q-Pulse and CRFManager in order to undertake their duties.
  • Use the Trust reporting systems DATIX, EPR, PiMS and other relevant reporting systems.
  • Ensure that all paper based systems are maintained securely.
  • Oversee the storage and archiving of CRF records in accordance with the relevant procedures and requirements.

General

  • The post holder will maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of clinical research. They will act as the CRF expert on quality matters pertaining to early phase clinical trials.
  • Possess excellent communication skills, allowing the post holder to justify their decisions and influence others; communicating effectively and calmly in difficult situations.
  • Maintain good working relationships with academic and service departments in order to promote effective teamwork.
  • Be able to work autonomously adhering at all times to departmental operating procedures and protocols.

Job description

Job responsibilities

Quality Assurance in the Clinical Research Facilities

  • Maintain the systems which provide assurance of the quality of clinical research activity undertaken within the four arms of the CRF and wider BRC as required.
  • Be responsible for the management of the CRF system for data quality control checks required to maintain the MHRA Phase I Accrediation, escalating issues to CRF Management as necessary and facilitating oversight.
  • Liaise with research teams to ensure time critical QC checks are performed ahead of Safety Review Committee meetings and any discrepancies addressed.
  • Plan and perform QC checks to a high degree of accuracy, reconciling data held in electronic data capture systems (eCRFs) with source data held in electronic health records for example EPR, enoting and CIS Mosaiq for selected studies running in the CRF and out in the wider R&D directorate (as required).
  • Ensure that paper-based and electronic documentation is maintained to the high standards expected upon audit and regulatory inspection for relevant CRF-managed studies and support colleagues from external research teams to do the same.
  • Recognise and respond to research governance and quality issues that might arise during quality control checks.
  • Develop tools to permit review of results of quality control checks and develop system metrics to allow assessment of compliance with quality standards.
  • Prepare and deliver practical training on specific quality assurance processes to allow staff across R&D to engage in and support data quality control as required and act as a Subject Matter Expert for data quality control.
  • Act as a Lead User for Q-Pulse, supporting the Deputy R&D / QA Manager to manage staff profiles and access, and document distribution within the system. Assist in the generation and management of Q-Pulse reports and the implementation of software updates.
  • Support the Deputy R&D / QA Manager in operating help facilities via the CRFQuality in box.
  • Participate in the hosting of regulatory inspections and audits as required.
  • Promote a Quality Culture among CRF staff, users and the wider clinical research community.
  • Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
  • Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and /or SOPs, responding appropriately and escalating action as required.
  • Participate in Good Clinical Practice audits of research studies running in the CRF and on occasion within the wider Trust as part of the audit programme implemented by the R&D/BRC Quality Assurance Manager.

MHRA Phase I Accreditation

  • Develop and maintain expert knowledge of the MHRA Phase I accreditation requirements and associated guidelines, and how they apply in the CRF operational context.
  • Work closely with high-level stakeholders across the CRF and within research teams to implement the plan for maintenance of Phase I accreditation under the supervision of the R&D/BRC and Deputy R&D /BRC QA Manager.
  • Recognise and escalate any risks to the CRF Phase I accreditation.

Information and Data Management

  • The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and the CRF specific software such as Q-Pulse and CRFManager in order to undertake their duties.
  • Use the Trust reporting systems DATIX, EPR, PiMS and other relevant reporting systems.
  • Ensure that all paper based systems are maintained securely.
  • Oversee the storage and archiving of CRF records in accordance with the relevant procedures and requirements.

General

  • The post holder will maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of clinical research. They will act as the CRF expert on quality matters pertaining to early phase clinical trials.
  • Possess excellent communication skills, allowing the post holder to justify their decisions and influence others; communicating effectively and calmly in difficult situations.
  • Maintain good working relationships with academic and service departments in order to promote effective teamwork.
  • Be able to work autonomously adhering at all times to departmental operating procedures and protocols.

Person Specification

Qualifications / Education

Essential

  • Relevant degree in Biological Sciences / Medical related field Or Relevant demonstrable experience in clinical research with knowledge relating to Quality Assurance equating to a degree level.

Desirable

  • MSc in clinical research

Previous Experience

Essential

  • Recent experience of aspects of management and conduct of clinical research including Clinical Trials of Investigational Medicinal Products (CTIMPs) and a high level of knowledge relating to EU and UK legislation and regulations (UK Statutory Instruments for clinical trials) and ICH Good Clinical Practice, gained in either a pharmaceutical company, contract research organisation, NHS or academic setting.
  • Responsibility for a system, process or activity in a quality capacity e.g. Management of protocol amendments or deviations
  • Experience of clinical trial quality control e.g. monitoring or related activities

Desirable

  • Experience of trials in all phases of research particularly Phase I clinical trials
  • Familiarity with the MHRA Phase 1 Accreditation requirements
  • Project management experience including use of project management tools and presentation of project plans to senior colleagues

Skills / Knowledge / Ability

Essential

  • Understanding of regulatory requirements as they relate to QA
  • Ability to demonstrate technical knowledge and a high level of skill in performing QC activities
  • Exceptional levels of accuracy and attention to detail
  • Strong problem solving skills
  • Ability to identify and prioritise work
  • Ability to identify and escalate risks appropriately
  • Excellent communication skills; Ability to communicate effectively with roles at all levels within the organisation and negotiate effective outcomes; Delivering presentations including complex content to a multidisciplinary audience
  • Providing training on quality assurance processes to staff across R&D as required

Desirable

  • Experience of training others
Person Specification

Qualifications / Education

Essential

  • Relevant degree in Biological Sciences / Medical related field Or Relevant demonstrable experience in clinical research with knowledge relating to Quality Assurance equating to a degree level.

Desirable

  • MSc in clinical research

Previous Experience

Essential

  • Recent experience of aspects of management and conduct of clinical research including Clinical Trials of Investigational Medicinal Products (CTIMPs) and a high level of knowledge relating to EU and UK legislation and regulations (UK Statutory Instruments for clinical trials) and ICH Good Clinical Practice, gained in either a pharmaceutical company, contract research organisation, NHS or academic setting.
  • Responsibility for a system, process or activity in a quality capacity e.g. Management of protocol amendments or deviations
  • Experience of clinical trial quality control e.g. monitoring or related activities

Desirable

  • Experience of trials in all phases of research particularly Phase I clinical trials
  • Familiarity with the MHRA Phase 1 Accreditation requirements
  • Project management experience including use of project management tools and presentation of project plans to senior colleagues

Skills / Knowledge / Ability

Essential

  • Understanding of regulatory requirements as they relate to QA
  • Ability to demonstrate technical knowledge and a high level of skill in performing QC activities
  • Exceptional levels of accuracy and attention to detail
  • Strong problem solving skills
  • Ability to identify and prioritise work
  • Ability to identify and escalate risks appropriately
  • Excellent communication skills; Ability to communicate effectively with roles at all levels within the organisation and negotiate effective outcomes; Delivering presentations including complex content to a multidisciplinary audience
  • Providing training on quality assurance processes to staff across R&D as required

Desirable

  • Experience of training others

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Clinical Research facility 15F Tower Wing Guy's Hospital

Great Maze Pond

London

SE1 9RT


Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)


Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Clinical Research facility 15F Tower Wing Guy's Hospital

Great Maze Pond

London

SE1 9RT


Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)


Employer contact details

For questions about the job, contact:

R&D / BRC Quality Assurance Manager

Sarah Ruiz

sarah.ruiz@gstt.nhs.uk

07585888895

Details

Date posted

13 May 2022

Pay scheme

Agenda for change

Band

Band 6

Salary

£38,768 to £46,124 a year p.a. inclusive of HCA

Contract

Permanent

Working pattern

Full-time

Reference number

196-BRC1769

Job locations

Clinical Research facility 15F Tower Wing Guy's Hospital

Great Maze Pond

London

SE1 9RT


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