Sponsorship Portfolio Manager

University Hospital Southampton NHS FT; Southampton; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

NHS discounts

35 days paid holiday pro rata

Generous pension scheme

Job summary

University Hospital Southampton NHS Foundation Trust invites applications for a Sponsorship Portfolio Manager within the Research & Development Department. The role oversees sponsor oversight for Trust-sponsored studies and ensures compliance with legislation and guidance.

The position involves developing oversight processes, advising researchers, and coordinating with grants, contracts, CROs and CTU. On-site work is required at least two days per week with flexible options where service needs

Qualifications

• Educated to degree level or equivalent knowledge in research.
• Experience in medical research methodology and clinical trial regulations (GCP).
• Evidence of continuing professional development (CPD).
• Experience with NHS or commercial health research settings.
• Familiarity with research governance and quality assurance systems.
• Training in monitoring of clinical research studies.

Responsibilities

• Develop and implement sponsor oversight processes for all Trust sponsored studies.
• Provide assurance that researchers and staff comply with governance and regulatory requirements.
• Review study protocols for regulatory compliance and monitor adherence to UK clinical trial regulations.
• Create and oversee Corrective and Preventative Action Plans as needed.
• Train research staff in governance, regulations and standard operating procedures.
• Prepare the Trust for regulatory inspections (e.g. MHRA).
• Collaborate with grants & contracts, delivery, CROs and CTU to support portfolios.

Skills

Research methodology

GCP knowledge

Research governance

Quality assurance

Monitoring experience

IRAS familiarity

CPD commitment

Training in monitoring

Education

Degree level education

Relevant research experience

Tools

IRAS

Job description

Job Overview

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Job Overview

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us. Please see below for a detailed job description for the role. Main duties of the job The Research & Development Department are looking for a Sponsorship Portfolio Manager. You will take responsibility for the approval and management of research studies sponsored by UHS, ensuring they are conducted in line with legislation and guidance. A key area of work will be the development of oversight processes and providing advice and guidance to researchers. The role is varied as it includes supporting different types of study and working with different teams including grants and contracts, delivery and external CROs and CTU. University Hospital Southampton NHS Foundation Trust and University of Southampton partnership is recognised as a centre of excellence in clinical research securing research funding in excess of £45m per annum. With state of the art clinical research facilities opened in 2010, the Trust, in partnership with the University is making excellent progress in achieving its aim of being one of the top research departments in the country. The sponsorship service operates 5 days a week and is responsible for upwards of 200 studies at any one time. Working for our organisation As one of the largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated ‘Good’ by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for staff recommending the hospital as a place to work or receive care. We support flexible working and will consider requests taking into account the needs of the service. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme. Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 30% lower than London and 17 schools rated outstanding by Ofsted. We believe that using technology wisely shows strong time management and commitment to innovation. However, personalising your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.

Detailed Job Description And Main Responsibilities

This post requires a dynamic, out-going person since a key aim in the role will be to develop relationships with researchers and to identify how best to ensure they are following guidance and legislation. Good IT skills would be advantageous and the successful applicant should be able to provide evidence of continuing professional development. The successful candidate needs to be able to pick up the role quickly and therefore needs to have a good knowledge of study set-up and delivery processes at UHS and to be familiar with the work of the Sponsorship team. As a Trust, we support flexible working where the needs of the service allow and you’ll have an opportunity to discuss this at interview. Although you will be required to work on site at least 2 days a week and this may be more if there are monitoring activities or an inspection announcement. We will give you in depth training on research governance as it applies to sponsored studies and the previous 4 holders of the position have gone on to be promoted into other roles. The role is very varied involving interaction with different teams and research portfolios. This role acts as a good grounding for future senior roles in research.

The Basic Duties Of The Role Include

• Develop and implement appropriate processes to ensure adequate sponsor oversight is in place for all Trust sponsored studies.
• Provide assurance to Trust Management that researchers, research support staff and the R&D central team are complying with:
• Research governance and regulatory requirements related to conducting clinical research.
• Relevant standard operating procedures
• Conduct on-site and remote monitoring across the Trust, and at other NHS organisations as appropriate.
• Review highly complex study protocols as part of sponsorship review and oversight and monitor to establish whether studies are being run in accordance with the UK Clinical Trial Regulations and GCP.
• Create and oversee execution of Corrective and Preventative Action Plans to deal with any findings appropriately.
• Ensure UHS sponsored studies are appropriately managed and supported and that the Trust delivers its sponsorship responsibilities as required and in accordance with regulations.
• Responsible for providing specialist training to research staff across the organisation in relevant research governance and regulatory requirements and standard operating procedures.
• Ensure implementation of policies relating to sponsorship, research management, study conduct and quality control.
• Contribute to development of local sponsorship and monitoring SOPs to ensure standards meet any changes to regulation.
• Have a key role in preparing the Trust for regulatory inspections relating to research e.g. MHRA.

Person specification

Qualifications, Knowledge And Experience

Essential criteria

• Educated to degree level or able to demonstrate equivalent level of knowledge/research experience relevant to the role.
• Experience of medical research methodology and statutory clinical trial regulations, GCP and research governance requirements.
• Experience of clinical trials in the NHS or the commercial health research sector.
• Evidence of continuing professional development.
• Evidence of ongoing/current Good Clinical Practice Training (GCP).
• Thorough understanding of the systems and processes which are used to support the delivery of high quality clinical care in a research environment.
• An understanding of R&D issues in the NHS.
• Knowledge of research governance and quality assurance systems to ensure safe systems for patients.
• Experience of previous training in monitoring of clinical research studies.

Desirable criteria

• Experience of working in a large teaching hospital or University.
• Commercial research experience.
• Previous experience in using IRAS for R&D applications.

Trust Values

Essential criteria

• Patients First
• Always Improving
• Working Together