Lead Research Nurse

Job description

Job responsibilities

Duties and responsibilities

• To be responsible for the management of nursing aspects of clinical research studies, including provision of robust feasibility reviews for studies involving patient consent.

• Jointly responsible, with the Head of RD&I, for the delivery of research to time and target.

• Responsible for providing professional, managerial and development liaison for research health professionals between wards and departments.

• Responsible for carrying out workforce planning to scope potential models for research nurse and research-AHP management across the Trust and use this information to inform longer-term planning.

• Responsible for service development and research strategy implementation, as directed by the Head of RD&I.

• To manage the clinical research support team. This is to include the team working to a defined set of competencies, with access to relevant training and for maintenance of training records for relevant staff.

• To ensure that all risks relating to the role are dealt with or escalated in accordance to Trust policy to ensure legal compliance, patient safety and data integrity.

• To deputise for the Head of RD&I as required.

Principal

• Act as provider of nursing expertise and to ensure Trust-wide compliance for research nurses with statutory responsibilities and requirements of the Nursing & Midwifery Council (NMC).

• Develop and implement nursing policies, procedures and guidelines in support of evidence based practice and expansion of the scope of professional practice with regards to implementing the Trust Research Strategy.

• Ensure robust local induction into the Trust for a new research nursing and AHP staff.

• Ensure that all research activity carried out by research nurses is performed according to ICH GCP guidelines, NMC code and UK Policy Framework for research and Health and Social Care; and all other legislation and guidance relating to clinical trials, including the Trust’s Standard operating Procedures and Internal Guidance.

• Ensure that Adverse events/Serious Adverse Events (AE/SAE) are reported according to Trust SoP’s and Research Protocols and that lessons are learnt, practice changed and sustained. This includes the use of the Trust’s Datix system to capture and report on risk events.

• Ensure patients/carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the out outside and during the course of the research or clinical trial in which they ae being asked to participate (i.e., informed consent).

• To ensure the safe custody and administration of drugs and therapeutic substances in accordance with legal requirements and in line with Standard Operating Procedures and Trust Policy to ensure all staff adhere to these standards.

• Support patients in making an informed treatment choice by providing specialist knowledge in relation to the disease process, treatment options and treatment side effects.

• Maintain high standards of care by personal example and conduct and to be a credible practitioner in the area.

• Act as a resource to other staff in the provision of on-going advice and support relating to effective informed consent, care of the patient during the clinical trial and adverse events.

• Maintain a strong and current working knowledge of relevant developments regarding clinical research delivery, regulation and governance.

• Maintain up to date knowledge of all guidelines and legislation relevant to role and to support the development of policies and internal guidance.

• Work together with lead researchers in the region to support the implementation of relevant NIHR initiatives. • Encourage and support nursing and associate staff in undertaking research projects.

• Promote professional development of nurses and associated staff by the use of research based practice.

• Make contact and maintain relationships with other research nurse groups within the region, developing mutually beneficial working practices.

• Responsible for the delivery of the Trust’s R&D Strategy in relation to areas of responsibility.

• Act as Budget Manager within delegated limits.

Delivery and Management of commercial & non-commercial research

• Responsible for the delivery of commercial research to time and target including robust feasibility, quick set-up, proactive study performance management to monitor progress of all studies and support sponsors and sites to ensure studies are delivered to time and recruitment target.

• Ensuring that NIHR performance metrics are adhered to in relation to 1st patient recruitment deadlines and site activation.

• Maintain good working relationships with all relevant external stakeholders including Industry, Non-Commercial Research Funders and Charities.

• Identify barriers to study recruitment/participation and develop approaches to overcome these, as they relate to areas of responsibility, and increase recruitment

• Support work to ensure that the Trust is prepared for regulatory inspections e.g., Medicines and Healthcare Products Regulatory Agency or Care Quality Commission ensuring successful outcomes for the Trust.

• Liaise with all members of the multi-disciplinary teams, to ensure optimal care provision when managing trial patients.

• Implement a specialist plan of care for trials patients. Provide continuity of care to patients and their carers throughout their treatment programme. Provide specialist advice about the disease process, treatment and management of side effects.

People Development

• Responsible for the effective recruitment and selection of staff in line with the Trust’s recruitment Process

• Ensure staff are appraised annually, have clear objectives which align to department and corporate objectives and personal development plan.

• Identify training and development needs of staff in line with departmental and Trust Objectives and ensure all new staff receive core and departmental induction.

• Communicate complex clinical trial/research information to a range of healthcare staff to ensure understanding of research/trials requirements and secure support for research.

This job description may be subject to change according to the varying needs of the service. Such changes will be made after discussion between the post holder and the manager. All duties must be carried out under supervision or within Trust policy and procedure

Person Specification

Qualifications

Essential

• Registered Nurse on the appropriate part of the NMC register with broad
• clinical experience
• Possession of a health/research related degree or equivalent
• Background in research and development, science or healthcare
• Relevant Masters level degree or equivalent experience

Experience

Essential

• Working within NHS setting to deliver commercial and non-commercially
• funded research
• Experience of managing/leading a team and co-ordinating workload
• Participation in Policy Development and implementation
• Understanding of research delivery issues
• Appreciation and understanding of clinical research methodologies and
• trials organisation
• Professional leadership at an operational level
• Experience of supporting service users and/or their carers in research
• involvement
• Relevant Line Management of research staff

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.

Employer details

Employer name

The Princess Alexandra Hospital NHS Trust

Address

The Princess Alexandra Hospital

Harlow

Essex

CM20 1QX

Employer's website

https://www.pah.nhs.uk (Opens in a new tab)