Senior Clinical Research Nurse/Midwife

Job overview

This is an exciting opportunity for an experienced research nurse or midwife to join a highly motivated research management team and help us deliver our ambition to grow our clinical trials portfolio across the Wigan Borough and bring novel treatments and therapies to Wigan residents.  WWL has a reputation in delivering novel treatments in orthopaedics (e.g. hip and other joint replacements) and in recent years has developed a track record delivering high quality in clinical trials in many specialities.

The Team works closely with NHS clinicians, universities and industry partners and is a partner of the Greater Manchester Commercial Research Delivery Centre funded by the National Institute for Health and Care Research (NIHR CRDC-GM).  Through these collaborations we will offer our local population the opportunity to take part in research studies associated with their existing clinical conditions and with preventative research programmes.

This role is primarily based at Clinical Research Hub, Ashton-in-Makerfield.

Please note that this vacancy may close early if a sufficient number of applications are received.

Main duties of the job

The post holder will be one of two Senior Research Nurse Managers responsible for leading and developing research services with senior research management colleagues and co‑ordinating delivery of a portfolio of clinical trials. The role includes feasibility and risk assessment, supporting trial set‑up, and ensuring safe delivery to successful completion while meeting and exceeding national key performance standards. They will ensure Standard Operating Procedures (SOPs) are fit for purpose, fully utilised by the research delivery team, and aligned with Health Research Authority (HRA) guidelines, Good Clinical Practice, Clinical Trials Regulations and all relevant laws safeguarding research participants. Working with the multidisciplinary team, the post holder will develop and improve SOPs and provide training to support high‑quality research by the Research Delivery Team. They will play a key role in implementing hospital and Research Network objectives to enhance research performance and development. WWL’s Research Strategy 2022–26, Research for All, sets out the Trust’s commitment to growing research, strengthening collaborations with Health and Care Partners, embedding research and innovation within partnerships, increasing commercial research, and expanding the number and diversity of staff involved in delivering research and innovation for the benefit of patients, staff and the Trust

Detailed job description and main responsibilities

Clinical Research Co-ordination

• Work autonomously in all areas of practice relating to clinical research.
• Evaluate research protocols, patient information and GP letters.
• Oversee the submission of regulatory and research applications and ensure that all approvals have been gained prior to research studies commencing (HRA/Research Ethics Committee, Research Department, MHRA, FDA, ARSAC, IRMER) including the submission of protocol amendments, annual updates and closeout reports to relevant agencies.
• Undertake the feasibility and risk assessment of clinical trial protocols.
• Ensure Case Report Forms are completed accurately and in a timely manner.
• Ensure all clinical trial activities are recorded in appropriate systems to support objectives.
• Initiate new recruitment strategies for recruiting patients to clinical trials.
• Ensure all trial related activities comply with SOPs and ICH/GCP.
• Work with the Research Network, Research Department and Sponsors in the preparation and negotiation of financial contracts for individual trials.
• Arrange and facilitate clinical trial related meetings.
• Disseminate information by preparation and presentation of research papers/posters for local, national and international meetings and conferences, as appropriate.

Clinical Service and Professional Responsibilities

• Lead and develop the clinical research services to achieve local and national key performance standards and objectives.
• Assimilation of highly complex information relating to clinical trials and communication to colleagues and patients at a level appropriate to their understanding. Ensure highly sensitive information is communicated to patients, relatives and carers regarding prognosis.
• Demonstration of expert knowledge in specialist area to maintain clinical excellence.
• Set up processes/patient pathways in specialist research areas to promote a cost-effective timely service for individual protocols (specialist clinics).
• Be fully aware of targets both local and national and in conjunction with the multi professional team utilising resources available to meet these targets.
• To act as a primary contact point for the research nurses and other healthcare professionals caring for the patient.
• Responsibility for maintenance and development of professional knowledge and practice by attending mandatory and specialist training (e.g. ICH GCP) in accordance with local policy and research governance.  Ensuring care delivery standards in accordance with trial protocol, local policy, NMC Code of Practice Conduct and current best practice.
• Promote, monitor and maintain best practice in health and safety and security.
• Development and maintenance of a high-quality service by:

a.    Developing specialist Standard Operating Procedures

b.    Developing a competency framework for induction and development of research nurses/AHPs to ensure standardisation of good clinical practice.

• Ensure appropriate support and information for non-research staff in the delivery of protocol driven treatment for all patients.
• Participate in the process of monitoring and audit of studies within research team.
• Will be required to work at other hospital sites within WWL.

Personal Education, Training and Development

• Maintain professional development whilst evaluating own specialist knowledge and practice through a process of appraisal and personal development planning.
• Promotion of clinical research nurse/practitioner’s roles as an integral part of the healthcare system.
• Participation in trust-wide education programmes and study days.
• Provide clinical supervision to Research Staff in the Research Delivery Team.
• Ensure that clinical supervision is obtained on a regular basis.
• To keep up to date with departmental, Trust, UK and EU developments for the management of clinical research ensuring timely, effective implementation of changes.

Responsibility for Human Resources and Teaching

• To assist research management team in ensuring all members of the research team undergo regular and effective appraisal, and to support appropriate training and development opportunities in line with role requirements. Perform individual PDRs/KSF as appropriate.
• Lead on the development of specialist study days
• Provide specialist education and training in relation to clinical trials to other healthcare professionals, including support and guidance to colleagues on the EU Directive and ICH/GCP.
• Act as a resource to the public and other healthcare professionals (both locally and nationally) on the availability of clinical trials within own specialist area.
• Contribute to the development of members of the research team.

Be responsible for the development of members of the research team.