Band 6 Agile TRU Clinical Research Nurse

Job summary

The post holder supports and coordinates the GCP compliant setup, delivery and close down of a portfolio of research studies across the Transplant Renal and Urology ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate governance oversight of the portfolio.

Main duties of the job

Following supporting the setup of studies, the research nurse will facilitate and aid recruitment of patients.

The role will include identifying, consenting and following up suitable patients for clinical research working autonomously within professional practice guidelines and within the Research Governance Framework.

The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials.

The post holder will manage a caseload of participants across Transplant Renal Urology where needed.

They will have duty of care in supporting them and their families throughout their participation in any research activity.

They will also act as a patient advocate providing support and oversight as required.

In addition, the research nurse will coordinate the portfolio of clinical research studies supporting and have oversight of the study set up, delivery (including data collection and site file maintenance) study close down and archiving.

The post holder will play a key role in ensuring that any research is undertaken within the departments safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006.

About us

They will work across Transplant Renal Urology where needed, to support teams to ensure the successful working of the clinical research projects they are assigned to.

Where needed, they will supervise and mentor other staff, acting as line manager, whilst actively contributing to evaluation and improvement of the service.

The post holder will work onsite and expected to work across Guy's Hospital, St Thomas' Hospital and in the community clinics as needed.

• Key duties/responsibilities
• Clinical and Communication Responsibilities
• Manage a caseload of participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice), Trusts policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations, Data Protection Act and Human Tissue Act.
• ensuring that the clinical trial protocol is adhered to at all times.
• Devise, implement and evaluate strategies for identifying eligible participants for research studies, including by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
• Participate in the informed consent process acting as a resource and support to participants and their families.

For appropriate studies take informed consent and ensure on-going consent in accordance with the necessary Trust research governance arrangements and necessary competent regulatory authority Regulations and International Conference on Harmonisation of Good Clinical Practice (ICH GCP)

• Coordinate the research participant pathway from screening through to study closure.
• Set up, collect and maintain adequate trial data and documentation via completion of participant records/case reports forms and investigator site files, ensuring the necessary information is documented in the electronic medical notes and databases, and communicated with clinical teams.
• Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal investigator or co-investigator.
• Undertake a range of clinical tasks in line with personal, professional competencies and as stipulated in approved study protocols such as blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
• Perform tasks requiring clinical and laboratory skills, including drug administration and clinical observation, phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories as stipulated in approved protocols and laboratory manuals as required.
• Have responsibility for the correct administration and custody of medicines according to Trust policy.
• Responsible for safe tracking, storage, efficient transport and robust documentation of participants samples.
• Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
• Report any side effects or adverse events according to protocol guidelines and within the required timeframe.
• Deal with concerns raised by participants and visitors in a proactive manner and take remedial action as necessary.
• Report to the senior clinical research staff any clinical incidences. Assist in managing incidents, accidents and complaints in accordance with Trust Policies.
• Manage clinical incidents effectively.
• Carry out planned care required by the clinical trials protocol for participants and patients without direct supervision
• Responsible for recruiting to, and following up, patients within studies including both interventional and observational clinical studies working closely with multidisciplinary clinical teams
• Act as a patient advocate enabling patients to make informed choices concerning their involvement in the clinical trials and ensuring advice and information is provided.
• Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocol.
• Assist and advise staff, both registered and unregistered in the delivery of care to the volunteer.
• Report any deviation from normal practice or clinical trial protocols to senior staff and contribute to and implement agreed corrective and preventative actions.
• Deal with concerns raised in a proactive manner and take remedial action as necessary.
• Administration
• Assist and co-ordinate in the process of gaining local regulatory approvals (ethics, HRA, local capacity and capability and Sponsor approvals).
• Assist in the review of research study protocols and identify resource implications for the site.
• Liaise with study set-up teams to facilitate smooth and effective study set-up.
• Assist in completing submissions to Research & Development departments.
• Process amendments and disseminate information to relevant departments.
• Participate in the collation of data, including performance data.
• Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.
• Ensure timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
• Actively work to achieve study accrual targets including engaging with the research team and clinical teams to overcome barriers to participant enrolment.
• Monitor patient recruitment and data collection week by week, reviewing recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.
• Organise and facil ite Sponsor meetings and visits, including site qualification, monitoring and close-out, representing the Trust in a professional and positive manner.
• Ensure that all study documentation is effectively archived as required.
• Assist in the provision of information to allow for invoices to be raised for payments where appropriate.
• Create and maintain invoice tracking for each study in conjunction with clinical team, according to team processes as required.
• Build strong professional relationships with other departments in order to promote a good working environment integration of research and open channels of communication.
• Educate appropriate medical and nursing personnel and departments on portfolio of research studies and protocol specific requirements.
• Maintain a dialogue of progress with the lead Clinical Research Nurse, Research Matron/Manager and research team leads.
• Participate in the presentation of research findings within the Trust research network.
• Provide cover when necessary for annual leave, study leave, sick leave.
• Plan, organise and deploy staff according to ability and workload in order to meet volunteer needs.
• Ensure that nursing practices comply with Trust policies and procedures
• Communicate effectively at all times and maintain a harmonious working environment.
• Maintain a safe environment in accordance with the Health and Safety at Work Act.
• Assist in managing and reporting of incidents, accidents and complaints in accordance with Trust policies and procedures.
• Ensure equipment is in good working order, and report appropriately when defective
• Participate in audits e. g. those undertaken by the Medicines and Health Care Regulatory Authority (MHRA) nursing audits and clinical benchmarking exercises and suggest any change to improve standards
• Ensure the economical use of resources
• Contribute to the overall control of the ward or departmental budget and identify areas where cost improvements can be made
• Actively participate in and support the development of the clinical research.
• Promote and participate in the implementation of policies within the Directorates and to ensure compliance with necessary Trust, Government and EU Directives.
• Set up and maintain accurate documentation in clinical trial documents and databases, case report forms, investigator site files, trial master files and patient notes.
• Ensure that clinical trials are effectively archived and then destroyed once approved as required.
• Management and Leadership
• Provide specialist advice and training to colleagues as relevant to your role.
• Supervise, train or mentor new or more junior staff as required.
• Line manage appropriate members of the team, oversee their development needs and ensure annual performance development reviews are completed if required
• Ensure implementation of policies and highlight changes where needed.
• Proactively make recommendations to improve the quality of service delivery.
• Report incidents in line with Trust processes and support team leaders in investigating and resolving issues.
• Act up for senior research nurse as required.
• Act as a role model for excellence in research delivery.
• Take active role in department training programme.
• Assist with the preparation of posters/research papers for meetings, conferences or publications.
• Represent the research team at local, national and international forums.
• Participate and attend investigator meetings and conferences when required.

Person Specification

Knowledge/ Qualifications

Essential

• Level 1 Registered Nurse NMC (Adult or RSCN) Registration with previous acute NHS experience
• Educated to degree level or above
• GCP certificate

Desirable

• A Clinical Research qualification
• ILS certificate
• Previous experience

Essential

• Extensive experience of working within the NHS as a qualified nurse
• Experience with accessing and managing research data, databases, and Excel Spreadsheets
• Experience in coordinating the setup and delivery of Clinical Research in NHS

Desirable

• Experienced and competent in the management of patients within the speciality
• Line management experience

Skills

Essential

• Competency in Venepuncture, cannulation, medication administration including IV drugs and IV infusions
• Able to acquire in-depth knowledge to organise, co-ordinate and deliver research protocols and communicate this to multi-disciplinary team and participants
• Ability to interpret patient records and extract data accurately
• Ability to lead, teach, supervise and mentor others in all aspects of clinical research delivery.
• IT skills including use of email and office packages.

Desirable

• Proficient with basic laboratory skills and able to mentor others
• Ability to perform clinical activities specific to speciality
• 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).

#J-18808-Ljbffr