Job Description

The Oncology and Haematology Clinical Trials (OHCT) team manages clinical trials within Guy's & St Thomas' NHS Foundation Trust (GSTFT). The team has an excellent reputation nationally and globally in providing excellent patient care and putting their safety at the core of our practice. GSTFT value research, the work we do contributes to finding new cancer treatments and improving patient's quality of life.



As a band 5 you will have a fantastic opportunity for training and career development within the specialty of GI or Skin research nursing. You will be working closely with experienced research nurses, doctors and other members of the multi-disciplinary team in caring for Oncology patients within clinical trials.



The role will include identifying patients suitable for clinical trials and support them and their families throughout their participation in clinical trials.

You will require:

Substantial clinical experience



Accuracy and attention to detail



Ability to work autonomously and have good skills in time management



Excellent communication and interpersonal skills



Can balance clinical work and non-clinical work as per research requirements



The post holder will be expected to manage a caseload of patients and have the duty of care in supporting them and their families throughout their participation in clinical trials. The role will include identifying suitable patients for clinical trials and work autonomously within professional practice guidelines and within Research Governance Framework.



The post holder will also provide a full administrative service to the tumour specific research team. They will have a pivotal role in the running of national and international phase I, II, and III oncology and clinical trials.



Responsibilities will include the creation and maintenance of site files, formulating worksheets, the collection and transcribing of trial data, completing case report forms and the maintenance of a database of trial activity.



As part of Kings Health Partners, the Oncology and Haematology Clinical Trials (OHCT) team is made up of fifty plus staff members consisting of Research Nurses, Clinical Research Practitioners, and the Safety & Support Team at Guys' and St Thomas' NHS Foundation Trust. We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups.



We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies.



Our mission statement is 'Improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical trials'.



Clinical research



Work autonomously to manage a caseload of patients acting as a professional

in ensuring a duty of care to the patient and their families



Identify patients suitable for entry into clinical trials by attending clinics

(screening notes/consultant referral) and Multidisciplinary Team (MDT)

meetings



Participate in the informed consent process acting as a resource and support to patients and their families



Co ordinate the research patient pathway from screening through to trial

closure



Advise and train the local nursing team who administer trial drugs, be aware of and report any side effects as outlined in the protocol



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



Keep up to date with current practices for cannulation, phlebotomy, care of patients with Central Venous Access lines and handling and administration of cytotoxic chemotherapy



Act as a role model for excellence in oncology based research



Lead on a portfolio of trials and coordinate patient participation, paying

particular attention to accurate data collection and transfer and version control of essential documentation



Liaise with the clinical team to organise and ensure that trial specific

investigations are undertaken according to the protocol and obtain the results



Liaise with trial pharmacy to co-ordinate the availability and dispensing of trial drugs if required



Process blood samples according to the trial-specific lab manual and organise the storage and shipment of protocol specific samples

Work in accordance with all regulatory requirements including:

local Standard Operating Procedures (SOPs), Good Clinical Practice, (GCP) European Directives, Medicines for Human Use (Clinical Trials), Regulations Research Governance Framework for Health and Social Care, Human Tissue Act



Lead on stock control and ordering of consumables



Organisational



Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient's medical notes and trial file is transcribed accurately.



Prepare the relevant essential documentation required when setting up a trial.

Assist in completing submissions to Research & Development Department.



Create and maintain the file of current protocols and patient information sheets, ensuring version control. Be responsible for the maintenance of the Investigator Site Files.



Assist in the creation and maintenance of good office systems for the

smooth running of the service.



Deal with data queries in a timely and efficient manner.



Organise and prepare documentation for audit and monitoring visits.



Provide information to allow invoices to be raised for payment where appropriate.

Arrange, attend and record minutes for research and other relevant departmental meeting.



Actively seek to develop the role to take account of changing requirements of the service. Portfolio Management and Development



Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials on site



Process amendments and disseminate information to relevant departments



Assist in the provision of information to allow for invoices to be raised for payments where appropriate



Build strong professional relationships with other departments in order to promote a good working environment



To report clinical incidents as per Trust policy and local SOP



Maintain a dialogue of progress with the Research Team Leader



Attend weekly team handover meetings



Provide cover when necessary for annual leave, study leave, sick leave.



Further information on the role and its requirements can be found in the attached job description and person specification documentation