The post holder supports and coordinates the GCP compliant setup, delivery and close down of a portfolio of research studies across the Pain and Neurology departments, and the wider Medical Specialties portfolio (Ophthalmology and Diabetes & Endocrinology) where needed, ensuring teams are supported to setup and deliver studies in a timely manner by providing appropriate governance oversight of the portfolio.
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 the Pain and Neurology departments, and the wider Medical Specialties portfolio (Ophthalmology and Diabetes & Endocrinology) where needed. They will have duty of care in supporting them and their families throughout their participation in any research activity. 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 wellbeing 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.
In conjunction with the other members of the team, they will facilitate the production of good quality of research.
Medical Specialities
This role will spend the majority of their time supporting our Pain and Neurology research portfolio, but may also support research taking place across other areas of Medical Specialties when needed.
Pain
The Guys and St Thomas (GSTT) Pain Management Centre is the largest NHS Pain Management service in the UK and has a well-established and proven track record of excellence. It has subsequently developed a broad range of Pain Management knowledge, expertise, experience and understanding across a range of chronic pain conditions.The GSTT Pain Management Centre is world renowned in Neuromodulation Therapies.Different specialists across the pain services work together to understand how pain is impacting patients’ live and to develop treatment plans aimed at reducing their pain.The pain and neuromodulation research team are actively involved in ongoing research into chronic pain conditions and the development of interventions to treat them.
Neurology
Our Neurology team provide diagnosis and treatment for diseases of the nervous system.
Neurology is a broad specialty covering lots of different conditions. Specialities covered include:
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),Trust’s 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.
· Organise and facilitate 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.
Education and Professional Development
· Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
· Contribute to updating, developing and implementing Standard Operating Procedures (SOPs).
· Undertake an Individual Performance Review annually with your Line Manager.
· Assist in the education and support of health care professionals to enable them to care for clinical trial patients and recruit to clinical trials where appropriate.
· Maintain an up to date knowledge of research related topics particularly related to clinical trials.
· Act as a role model, mentor and preceptor to the nursing team.
This advert closes on Sunday 16 Feb 2025