Job summary
The post holder will develop, implement and maintain sponsor oversight management systems, including audits plans, to assure the quality of clinical research sponsored or co-sponsored by GSTT is in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the UK Policy for Health and Social Care, ICH Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations (as amended from time to time), the Human Tissue Act, the Data Protection Act and the Mental Capacity Act.
Main duties of the job
You will be an experienced ICH-GCP research auditor, who is an expert in sponsor oversight management systems (e.g. audit plans, monitoring, trial committees, research databases, risk-assessments) who will further develop the quality management systems of clinical research sponsored or co-sponsored by GSTT. To do this you will be knowledgeable of research funding, approvals process and the regulations of clinical trials in the UK.
As a research audit lead the post-holder will work autonomously and collaborate with other QA and clinical trial management professionals, across the trust, university and KHP Clinical Trials Office. Working in a complex organisation with multiple partners and competing pressures, you must be able to influence change, negotiate and act with diplomacy to improve quality standards.
About us
This is a dynamic, lively and diverse department with a high- level of research activity who look forward to welcoming a new Quality Assurance expert in our team.
This is a part-time job: 0.8 WTE (30 hours or 4 days a week). We are open to flexible working arrangements such as compressed hours in line with the Trust Flexible working policy. However, the post-holder will be required to work in the R&D office at Guy's hospital a minimum of one day a week and as a senior member of the R&D office may on occasions be required to attend more frequently to support the team and when conducting on-site audits. The R&D office on the 16th Floor Guy's Tower will work across all hospital sites within the organisation and across KCL campuses. The post-holder will be required to visit other UK research sites and organisations e.g. CTUs and labs to conduct on-site audits.
Job description
Job responsibilities
The post-holder will develop, implement and maintain a clinical trial and GCP audit and monitoring programme, improving the R&D Quality Management System (QMS) with a particular focus on studies that are sponsored/co-sponsored by GSTT. This will include risk-assessments at grant stage and supporting the R&D sponsorship team of risk management during the set-up process. Responsibilities will include incident and breach management, CAPA, the establishment of sponsor oversight mechanism for third-parties e.g. selected CTUs and vendors, report and SOP and guidance document writing.
Along with in-depth technical knowledge about clinical trials, ICH-GCP and their regulations, the post-holder will have experience in trial monitoring and/or GCP auditing, change-management and be a skilled influencer who will collaborate with professionals at all levels including senior clinical investigators, KHP CTO, R&D clinical trials management platform, KCL RMID and RGO research delivery managers and staff and the wider R&D office. This is an exciting opportunity to promote and lead quality research culture across a complex organisation.
Job description
Job responsibilities
The post-holder will develop, implement and maintain a clinical trial and GCP audit and monitoring programme, improving the R&D Quality Management System (QMS) with a particular focus on studies that are sponsored/co-sponsored by GSTT. This will include risk-assessments at grant stage and supporting the R&D sponsorship team of risk management during the set-up process. Responsibilities will include incident and breach management, CAPA, the establishment of sponsor oversight mechanism for third-parties e.g. selected CTUs and vendors, report and SOP and guidance document writing.
Along with in-depth technical knowledge about clinical trials, ICH-GCP and their regulations, the post-holder will have experience in trial monitoring and/or GCP auditing, change-management and be a skilled influencer who will collaborate with professionals at all levels including senior clinical investigators, KHP CTO, R&D clinical trials management platform, KCL RMID and RGO research delivery managers and staff and the wider R&D office. This is an exciting opportunity to promote and lead quality research culture across a complex organisation.
Person Specification
Qualifications
Essential
- Educated to at least degree level preferably in a related subject area, e.g. a life science or clinical subject
- Evidence of ICH GCP Audit and Monitoring Training
Desirable
- Computer Systems Validation qualification
Experience
Essential
- Monitoring and auditing, co-ordination or managing clinical trials to GCP in pharmaceutical company, contract research organisation, NHS or academic setting.
- Risk and incident management experience in the NHS or pharmaceutical industry environment
- Experience of managing a team
Desirable
- Experience of research across a range of therapeutic areas including first in human and phase I, device trials
Skills, Knowledge & Abilities
Essential
- Strong ability to build successful relationships, influence and collaborate in a cross functional team and maintain a positive work environment with GST and KCL colleagues
- Ability to communicate complex information to members of the team and groups of health service staff
- Strong ability to problem solve
Person Specification
Qualifications
Essential
- Educated to at least degree level preferably in a related subject area, e.g. a life science or clinical subject
- Evidence of ICH GCP Audit and Monitoring Training
Desirable
- Computer Systems Validation qualification
Experience
Essential
- Monitoring and auditing, co-ordination or managing clinical trials to GCP in pharmaceutical company, contract research organisation, NHS or academic setting.
- Risk and incident management experience in the NHS or pharmaceutical industry environment
- Experience of managing a team
Desirable
- Experience of research across a range of therapeutic areas including first in human and phase I, device trials
Skills, Knowledge & Abilities
Essential
- Strong ability to build successful relationships, influence and collaborate in a cross functional team and maintain a positive work environment with GST and KCL colleagues
- Ability to communicate complex information to members of the team and groups of health service staff
- Strong ability to problem solve
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
