Job Description

The post holder will be responsible for co-ordinating an agreed portfolio of non-commercial and commercial clinical trials.



Responsibilities will include setting up clinical trials; identifying patients through MDT's/screening notes and increasing referrals through the data base; collecting data; interviewing; supporting and monitoring patients and data entry.



This patient population requires input from a compassionate and caring research professional, with experience caring for and managing patients with cancer; including working with the wider MDT to co-ordinate patient care.



For multi-centre trials led at KCH, the post holder will also be expected to support investigators and their teams at recruiting sites.

The post holder will work closely with the Liver Research Manager, Senior Research Nurse/Clinical Trials Coordinator, medical staff, the Clinical Nurse Specialist Teams, the transplant co-ordinators, radiologists and the pharmacy technicians.



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.



We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.



King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.



Clinical Responsibilities



Work in conjunction with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients, whilst working as part of a multidisciplinary team.



Maintain effective communication with patients, carers and professionals to ensure service delivery. Assist in screening patients suitable for entry into clinical trials. This will include attending clinics and Multidisciplinary Team (MDT) meetings.



Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.



With other members of the healthcare team, ensure patients are fully informed prior to entry in any

clinical trial programme.



Assist in consenting, randomising, allocating of treatment of patients.



Evaluate patient eligibility for clinical trial entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.



Act as a resource and support to patients and their relatives, explaining practical aspects of clinical

trials, assisting and supporting local nursing teams.



Act as key worker for patients while they are on the clinical trial, liaising closely with the clinical nurse

specialists to ensure appropriate care and advice provided.



Coordinate the collection of any blood samples required as part of the clinical trials and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.



Ensure the safe packaging and transport of biological specimens as per IATA regulations.



Support the administration of trial drugs (commensurate with education and training), be aware of and

report any unusual side effects, in association with local nursing teams.



Maintain adequate patients' records and ensure all relevant information is documented in the patient's

medical and nursing notes.



Responsible for accurate completion of Case Report Forms (CRFs).



Responsible for the collection, co-ordination and computerisation of data generated from the clinical

trials.



Provide continuity of care for patients and their carers throughout the trial programme. Provide specific advice and support as appropriate.



Ensure patients community care team are fully aware of patient's performance / progress while on the study so fully coordinated care is provided.



Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials

Regulations.



If appropriately trained, keep up to date with current practices for cannulation, phlebotomy and care

of patients with Central Venous Access lines.



Act as a resource for liver based research.



Portfolio Management and Development



Assist in the review of trial protocols and identify resource implications for the site.



Set up and maintain the TMF/ISF with essential documents.



Help organise initiation meetings.



Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of

patient



Ensure CRFs are completed accurately and in a timely manner.



Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor's SOP.



For network trials, ensure that accrual data is uploaded onto the NIHR CRN portal using the EDGE clinical trials database. Collect and provide information to allow for invoices to be raised for payments

where appropriate .



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.



Participate in the presentation of research findings within the Clinical Research Network South London and outside agencies as appropriate.



Report adverse incidents and near misses via the Trust's online incident reporting form.



Coordinate multi-centre trials (where appropriate). Together with the Kings Health Partners Clinical

Trials Office (KHP CTO):

Ensure all relevant documents and approvals are in place at each site prior to subject

recruitment.



Liaise with participating sites, identifying key staff and updating them on trial processes/changes to the protocol and ensuring centres are able to comply with the study protocol.



Help conduct initiation meetings (if required)



Collect data from sites, raise data queries and ensure data queries are resolved.



Training and Development



Attend the KHP CTO, NIHR CRN and CRN South London 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 hepatology treatments, research and nursing practice and use this knowledge to maintain high standards of care for Nurse trial patients.



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.



Professional



Act in accordance with local policies and procedures laid down by King's College Hospital Institute of Liver Studies.



Be responsible for maintaining a professional profile.



Work within the NMC Scope of Professional Practice, Conduct and Record Keeping.



Undertake an annual appraisal (internal performance review) to identify organisation and professional objectives and development needs.



General



The post holder has a general duty of care for their own health, safety and wellbeing 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 Trust

together with all relevant statutory and professional obligations.

To live and role model the King's Values of:

Understanding you Inspiring confidence in our care Working together Always aiming higher Making a difference in our community

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.



This job description is intended as a guide to the general scope of duties and is not intended to be

definitive or restrictive. It is expected that some of the duties will change over time and this description

will be subject to review in consultation with the post holder.



All employees must hold an 'nhs.net' email account which will be the Trust's formal route for email

communication.



Safeguarding



The Trust takes the issues of Safeguarding Children, Adults and addressing Domestic Abuse very seriously.

All employees have a responsibility to support the organisation in our duties by;

attending mandatory training on safeguarding children and adults familiarising themselves with the Trust's processes for reporting concerns reporting any safeguarding child or adult concerns appropriately

Infection control statement



The post holder has an important responsibility for and contribution to infection control and must be familiar

with the infection control and hygiene procedures and requirements when in clinical areas.

The post holder has an important responsibility for and contribution to make to infection control and must be

familiar with the infection control and hygiene requirements of this role.

These requirements are set out in the National Code of Practice on Infection Control and in local policies and

procedures, which will be made clear during your induction and subsequent refresher training. These

standards must be strictly complied with at all times.