Senior Research Nurse

Job overview

Need a new challenge?  We are looking for a skilled research nurse with the enthusiasm and drive to help us achieve our ambitious target of bringing the benefits of clinical research to an ever growing number of patients.

This is an opportunity to join the ambitious and forward-looking Research and Innovation (R&I) teams at University Hospitals of Northamptonshire (UHN) as a Senior Research Nurse (B6). Working across UHN you will be supporting the delivery  of commercial trial activity across multiple specialties.

Research and Innovation at UHN are a dynamic, active hubs of research activity with an excellent national track record of recruiting patients into commercial and non-commercial studies.  It consists of a generic team of highly-qualified and dedicated clinical and non-clinical staff delivering and supporting research activity across the hospital group.

You will have good organisational and communication skills, have proven experience of working in the  field of clinical research, a team orientated approach and the ability to plan and undertake work in an accurate, methodical and efficient manner. A good eye for detail is essential, as are excellent administrative and IT skills, alongside excellent clinical skills.

We would strongly encourage an informal visit prior to interview.

Main duties of the job

The Senior Research Nurse (B6) is expected to support the management and leadership of the research nurse team and administrative staff within the research team. They will have knowledge and understanding of the regulatory and legal frameworks related to the planning, undertaking and closure of clinical research studies, including Clinical Trials of Investigational Medicinal Products and therefore acts as a resource for staff, researchers, research participants and patients.

They will take a lead in ensuring the safe and effective delivery of a designated number of clinical research studies and contribute to maximising patient recruitment to those studies.

Detailed job description and main responsibilities

Unit Management

Manage a designated number of research studies

Maintain a safe environment, for patients, staff and visitors, ensuring that all control measures comply with NGH current policies and procedures, and any statutory requirements, including all Health and Safety and Clinical Governance arrangements

Use judgement in relation to competing demands for funding, staff and team resources

Contribute to the control of the research unit budget ensuring that adequate measures exist for delivery of the research studies

Respond to change in line with the needs of service provision

Responsible for the development and updating of team’s policies and procedures

Ensure that all record keeping within the department is appropriate, timely and clearly understood for the purpose of patient care, safety and data integrity

Education

• Identify own learning needs and proactively seek educational opportunities to fulfil them
• Develop skills in accordance with the NIHR CRN Competency Framework for research delivery staff appropriate to the Band 6 role

Strategic Role

Be a champion of clinical research

Support and influence the embedding of clinical research within the Trust

Foster good relationships with key division research leads / support departments /Institutes and partners to promote the efficient running of clinical trials and develop the Trust research portfolio

Contribute to the development and updating of research policies and procedures within NGH

Take an active role in the activities of professional forums and networks

Disseminate the results of research into clinical nursing practice

Staff Management

Maintain standards of practice in accordance with the legal rules and statutory regulations set out by the NMC or appropriate professional body

Support the professional and educational development of research team’s nursing, allied health professional and administrative staff, assisting in identifying needs and finding solutions

Support the training and ensure the appropriate supervision of research team’s staff, contributing to their mentorship and monitoring

Line manage research nurses and A&C staff within the team as and when agreed

Assist with the recruitment, selection, induction and orientation for new research nursing, allied health professional and administrative staff

Facilitate the team working effectively and cohesively together, developing the relevant clinical skills, delivering studies to time and target

Provide day to day management of the research team in the absence of the Clinical Research Managers, ensuring all staff and activities comply with trust policies and guidelines

To act as a role model in establishing good practice and establishing standards of care and management that should be adhered to 24hrs a day

Responsible for effective communication within the nursing teams ensuring that all members are well briefed on key departmental and corporate issues

Promote an approach to patients focussed on care and compassion, ensuring courtesy and respect at all times

Ensure that standard operating procedures are followed by all members of the research team

Instigate and oversee Quality Improvement projects in Research & Innovation

Study Set Up

Ensure all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation

Signpost to advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory and trust approval.

Have a detailed knowledge and understanding of research design and methodology

Contribute to the assessment of study protocols and advise on any safety, regulatory and logistical issues

Provide oversight for the set-up of a designated number of research studies within the team, acting as point of contact for R&I in the feasibility process

Project manage study set up with colleagues from around the Trust (support departments, finance etc.) and within the University of Northampton

Study Conduct

Support local Principal Investigators in meeting their responsibilities outlined in regulatory and legal frameworks

Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study

Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations.

Identify & screen appropriate study participants, in accordance with the protocol, & in conjunction with other members of the clinical & research teams

Receive informed consent for designated research studies as agreed within the protocol

Provide knowledge and demonstrate accurate attention to detail in documentation tasks, to include:

• Investigator Site File maintenance
• CRF completion
• Documenting source data

Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the division and wider UHN research community as appropriate.

Act as a resource to PIs in ensuring all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP, ISO 14155 and UHN Adverse Events Reporting policy

Where appropriate, liaise with the R&I department in identifying any barriers to recruitment and the running of the study; support the study team in developing strategies to mitigate them

Support the study team in ensuring all reporting to regulatory bodies, R&I and Research Networks (if applicable) is completed in a timely manner

Support the study team to ensure that all equipment used is appropriately checked and calibrated with supporting documentation retained

Liaise with Sponsors to ensure all arrangements for research governance for each study are in place

Study End

Ensure all data clarification issues are resolved quickly

Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations/ISO 14155 as appropriate.

Where appropriate, ensure a smooth transition from the research pathway back to the conventional treatment pathway