Clinical Research Nurse

Job summary
We are looking for an experienced, enthusiastic and motivated Research Nurse to join the GI Research Team within the Oncology and Haematology Clinical Trials service. This post will support the delivery of a high-quality and expanding portfolio of complex Haematology research studies.

The successful candidate will work as part of the GI Research Team, supported by the Team Lead and senior research staff. You will be involved in identifying patients suitable for entry into clinical trials by attending clinics, screening medical notes, reviewing consultant referrals, and participating in Multidisciplinary Team (MDT) meetings. You will contribute to the informed consent process, acting as a point of support for patients and their families, and assist in coordinating the research patient pathway from screening through to trial completion, including supporting trial set-up activities as required.

Applicants must be a registered adult nurse with evidence of continuing professional development. You should have extensive experience of clinical research in haematology within the NHS or a strong gastrointestinal clinical background with an interest in developing research skills. You will need excellent communication and interpersonal skills, the ability to organise and prioritise your workload, and the confidence to work both independently and as part of a multidisciplinary team while managing a patient caseload across several GI research studies

Main duties of the job

• Work autonomously to manage a caseload of complex GI trial patients, providing duty of care and ongoing support to patients and their families throughout participation.
• Work in accordance with the Research Governance Framework, EU Clinical Trials Regulations and ICH Good Clinical Practice (GCP), ensuring protocol compliance at all times.
• Identify eligible patients by attending various GI clinics, screening medical notes, reviewing consultant referrals, and participating in MDT meetings.
• Support the informed consent process by providing clear information and ensuring consent is obtained and documented appropriately.
• Coordinate the research patient pathway from screening through to trial closure, liaising with the trial set-up team and using trial-specific prompts where required.
• Maintain infection prevention and control standards, including minimising cross-infection risk and ensuring safe disposal of body fluids and blood products.
• Administration of investigational medicinal products (IMPs) and monitor, document and report adverse events/side effects as per protocol.
• Maintain accurate, contemporaneous clinical and research records in medical/nursing notes and trial documentation.

About us
OHCT sits within the Haematology Directorate, the team run and manage over 200 trials at any one time and cover all solid tumours and haematological malignancy and non-malignant diseases.

We have a dedicated team running the early phase studies and part of ECMC which is based in the clinical research facility.

Job responsibilities

• CLINICAL RESPONSIBILITIES Work autonomously within professional practice guidelines to manage a caseload of GI research patients, ensuring a duty of care and providing support to patients and their families throughout trial participation. Work in accordance with the Research Governance Framework, EU clinical trial requirements and ICH Good Clinical Practice (GCP), ensuring trial protocols are adhered to at all times. Identify patients suitable for entry into Phase 2-3 clinical trials by attending GI clinics, screening medical notes, reviewing consultant referrals, and participating in Multidisciplinary Team (MDT) meetings. Participate in the informed consent process, acting as a resource and source of support to patients and their families, ensuring consent is appropriately obtained and documented. Coordinate the research patient pathway from screening through to trial closure, supporting trial set-up activities (e.g. pathway prompts) in collaboration with the set-up team where required. Maintain infection prevention and control standards, including taking adequate precautions to minimise the risk of cross-infection and ensuring safe disposal of body fluids and blood products in line with Trust policy. Support delivery of trial treatments in collaboration with local nursing teams (including investigational medicinal products and advance therapy products ), and monitor, document and report adverse events/side effects in accordance with the protocol. Maintain accurate, contemporaneous patient records and ensure all relevant information is documented in medical and nursing notes and trial documentation. Complete trial documentation accurately, including Case Report Forms (CRFs), and support the collection, coordination and computerisation of data generated from clinical trials. Maintain clinical competence and keep up to date with current practice relevant to the role (e.g. cannulation, phlebotomy, central venous access device care, and safe handling/administration requirements for systemic anti-cancer therapy and investigational products as required).
• PORTFOLIO / STUDY DELIVERY (SUPPORTING ROLE) Assist with review of trial protocols and highlight practical, risk and resource implications to the Team Lead and relevant colleagues. Liaise with Clinical Trial Set-Up staff to support site set-up activities and contribute to feasibility discussions by highlighting patient pathway issues and potential mitigations to maintain patient safety. Support submissions and ongoing study administration as required (e.g. R&D documentation where applicable), and process amendments, ensuring information is disseminated to relevant departments. Work closely with the medical team and sponsor contacts to support coordination of on-study treatment and follow-up in line with protocol schedules. Contribute to accrual/activity reporting and provide information to support invoice generation where appropriate. Build effective working relationships across departments to support smooth trial delivery and a positive working environment. Provide education/updates to relevant clinical teams about the local portfolio and study requirements where appropriate. Participate in sharing research outputs (e.g. presentations of research activity/findings within the Trust and relevant networks) in line with service needs. Manage clinical incidents appropriately and promptly escalate/report incidents to the Research Team Leader in line with Trust processes. Maintain dialogue with the Research Team Leader regarding progress, workload and issues, attend team handover meetings, and provide cross-cover for colleagues during annual leave, study leave and sickness as required.
• PROFESSIONAL DEVELOPMENT Attend training and relevant education as agreed in the development plan, and attend investigator meetings and conferences when required. Take responsibility for maintaining professional registration and ongoing development in research practice and clinical care. Contribute to service development and quality improvement within the GI Research Team/OHCT service. Provide day-to-day support and guidance to less experienced colleagues/students as appropriate to role and competence (without formal line management responsibility). Participate in clinical supervision in accordance with NMC guidance and complete appraisal/performance review processes. Work in line with Trust policies including confidentiality/information governance, infection control, risk management and health & safety requirements.

Person Specification
Skills
Essential

• You have evidence of excellent communication and interpersonal skills
• Evidence of accuracy and close attention to details
• Ability to work autonomously and as a member of a small team, as well as part of the wider multidisciplinary team in relation to clinical trials
• You will have the dexterity and coordination needed for undertaking venepuncture, intramuscular, subcutaneous, and accuracy required for e.g. intravenous injections, syringe pumps and infusions.
• You will possess basic laboratory skills such as pipetting and centrifugation
• Ability to set direction and lead a team of research professionals

Desirable

• Immediate Life Support (ILS) accreditation

Experience
Essential

• Experience in clinical trials, teaching and mentoring as demonstrated by your individual portfolio (within the haematology nursing setting)
• Knowledge of clinical trials and the drug development process.
• Post registration experience in research nursing, managing own portfolio of trials
• Knowledge and experience of handling complex relationships
• Demonstrable leadership experience
• Experience of mentoring and developing

Desirable

• Understanding of research methodologies including phase I - IV clinical trials

Knowledge/Qualifications
Essential

• NMC Level One Registration - RN Adult
• ICH GCP & EU Clinical Trial Directive certificated
• Post-registration teaching qualification (e.g. 998 or mentorship course)
• Evidence of continuous personal, professional and academic development

Desirable

• Relevant post registration qualification
• Masters level qualification or demonstrable equivalent experience

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.

Certificate of Sponsorship
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).

UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).