Liver Research Data Manager

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King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and more than 15,500 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in the London Borough of Bromley.

Job overview

The Liver clinical trials team at King's are inviting applications for a clinical trials data manager to work alongside the clinical trials team on an exciting portfolio of commercially funded and investigator led studies in liver diseases.

The successful applicant will be an enthusiastic and motivated individual who will be responsible for assisting the liver research team with a variety of data management tasks. These will vary from administrative tasks, completion of paper and electronic data (with timely entry and query resolution), assisting with database set up and maintenance, auditing, assisting with monitoring visits, maintaining trial master files, archiving and supporting the senior research staff on a day to day basis.

Previous experience working within the area of clinical trials would be desirable but applicants with other experience that may be applied to this setting would be considered. Administration skills, IT skills, prioritisation and organisational skills along with excellent communication are essential for this role. You must also demonstrate the ability to manage your own work load effectively in a busy environment.

Knowledge of the research process, along with the structure of research within the UK and guidelines relating to Good Clinical Practice is preferred.

Informal visits are encouraged:

andrew.ayers@nhs.net 02032997615

Main duties of the job

• Responsible for accurate completion of Case Report Forms (CRFs).
• Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
• Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
• Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient under the supervision of clinical trial coordinator.
• Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC.
• Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.

Working for our organisation

King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts. We have 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.

King's College Hospital is a research active organisation, with world - class researchers working in key clinical specialities. Investigators at King's are active in winning peer-review grants and in leading innovative high quality studies to benefit patients. Well over 90% of the health research underway at King's College London was rated as world leading or internationally excellent in the recent Research Excellence Framework assessment. King's College Hospital plays a leading role in contributing to this.

The liver research team makes a key contribution to the overall research output at KCH. The largest of the delivery units; the team manages a multi-faceted portfolio of commercial and non-commercial trials across the spectrum of liver diseases, from basic science to phase 4 activity.

Detailed job description and main responsibilities

KEY AREAS OF RESPONSIBILITY

1. Clinical Responsibilities
• Responsible for accurate completion of Case Report Forms (CRFs).
• Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
• Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
• Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting nursing teams.
• Act as a resource for liver based research.
• Work in accordance with all regulatory requirements including:
- Local Standard Operating Procedures (SOPs)
- Good Clinical Practice
- Medicines for Human Use (Clinical Trials) Regulations
- Research Governance Framework for Health and Social Care
- Human Tissue Act

2. Portfolio Management and Development
• Maintain the TMF/ISF with essential documents.
• Help and organise initiation meetings.
• Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient under the supervision of clinical trial coordinator.
• Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor's SOP.
• Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.
• Inform appropriate medical personnel and departments of portfolio of clinical trials.
• Report adverse incidents and near misses via the Trust's online incident reporting form.
• Act as a link for Liver Clinical Trials team and KHPCTO and KCH R&I Department
• To organise and issue documents to visiting Sponsors and affiliates
• To contribute to the writing and maintaining of SOPs that cover the areas of responsible work, as supervised by the CTC.
• Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research.

3. Office Management
• Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms and arranging catering, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.
• Ensure the availability of office supplies, furniture and equipment and procurement of goods for the Clinical Trials team.
• Act as first point of contact for callers to the Liver Clinical Trials Team, and for telephone and written enquiries.
• Assist in organising patient appointments
• Manage an effective system for processing patient travel claims and liaising with Finance Department
• Type correspondence, memos, e-mails and other documents from audiotape, written copy, dictation or verbal instructions, and to generate own correspondence as required.
• File correspondences from Sponsors, and any patient related activity.
• To assist in adhoc tasks to support various developments, projects and events within the team.
• Ensure that accrual data is uploaded onto the UKCRN portal/EDGE and is reported to the SELCRN co-ordinating centre as required

3. Training and Development
• Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.
• Attend investigator/initiation meetings and conferences when required.
• Maintain awareness of current advances in treatments, research and nursing practice and use this knowledge to maintain high standards of care
• Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.
• Demonstrate the use of database systems and train colleagues and researchers.

4. Professional
• Actively participate in personal development together with line manager. Ensure performance is appraised following the Trust appraisal and KAD procedures.
• Develop a clear understanding of the service and the role. Also able to provide cover for colleagues in the area when necessary
• Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.
• Attend investigator meetings and conferences when required.

5. General responsibilities
• The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
• To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations.
• To observe and maintain strict confidentiality of personal information relating to patients and staff.
• To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
• Collect and provide information to allow for invoices to be raised for payments where appropriate
• Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.
• Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract.

Person specification

Education

Essential criteria

• Relevant degree or professional qualification or equivalent experience
• Advanced IT skills, ECDL or proven equivalent experience in MS Office, email and Internet browsers.

Experience

Essential criteria

• Excellent communication skills in English written and verbal

Desirable criteria

• Experience of report writing and analysis reporting to a range of audiences.
• Development of procedures and preparation of SOPs

IMPORTANT

• Check your email account regularly as this is how we will communicate with you
• If you delete the job from any of your accounts, you may be prevented from accessing further communications
• To enquire about your application or inform us of any changes in your circumstances, please contact the named person on this advert
• Please provide email addresses for referees where possible
• Click here to see the range of benefits we offer
• Please review the documentation on our recruitment microsite, particularly the Trust's criminal records checking policy
• All staff have a responsibility for safeguarding children and vulnerable adults and for ensuring they are aware of the specific duties relating to their role.
• Due to a high volume of applications, this advert might close before the displayed closing date. It is therefore recommended that you apply promptly

Equality and Diversity Information

King's College Hospital NHS Foundation Trust Annual Reports and Other Corporate Publications

King's Health Partners Academic Health Science Centre Website

King's College Hospital is part of King's Health Partners Academic Health Sciences Centre (AHSC), a pioneering collaboration between King's College London, and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts.

Employer certification / accreditation badges

Documents to download

• Job Description and Person Specification (PDF, 496.3KB)
• Denmark Hill Site Map (PDF, 1.2MB)
• Visa and Sponsorship Information (PDF, 352.6KB)