The Royal Brompton cystic fibrosis (CF) clinical trials department comprises of clinicians, academics, allied health professionals and admin/ finance members. The Brompton adult & paediatric CF centres are made up of world leading teams carrying out global, multicentre interventional and observational studies, in both adults and children, being led by Profs Davies, Simmonds and colleagues. The Brompton is the lead site for an early-phase, multicentre trial of CFTR gene therapy led globally by Prof Eric Alton this post has been created primarily to support this trial, whilst also working alongside the team across the CF trials portfolio.

You will be responsible for all matters relating to data collection/management, involving direct patient interactions and provision of administrative support for trial-related activities for the gene therapy study. This role requires the post holder to be able to handle a varied/extensive workload. Training will be provided in all aspects of the role.

You will support the other research taking place within the CF trials department, based at the Royal Brompton campus, close to the vibrant King's Road, Chelsea. You will be located in an office with a multidisciplinary clinical and research team allowing for networking/learning from other healthcare professionals. We encourage/support applicants in applicable career progression as a clinical research practitioner/research nurse including attendance at courses, seminars/conferences.

Main duties of the job

Identify/recruit participants for research studies in CF/other inherited respiratory conditions

• Frontline support to study participants by phone/in clinic. Demonstrate politeness, courtesy & sensitivity. Ensure enquiries are dealt with/followed up.
• Performance & review of clinical assessments, collection/processing of participants blood or other samples
• Maintain accurate/complete records. Always demonstrate awareness/compliance with local policies, procedures, guidelines/standards
• Maintain up-to-date skills/knowledge in the field of CF/clinical trials. Attend national/international conferences continuing professional development. Develop areas of personal interest in healthcare
• Contribute in the writing of research reports/publications

Essential:

Educated to degree level in a healthcare/science-related subject or have a Professional Nursing Qualification with valid NMC registration

• Experience of working directly with patients/ study participants in a clinical setting

Good understanding of clinical terminology

• Proven experience of organisational/record keeping/time management skills. Accurate data management, knowledge of handling confidential information. An understanding of current legislation/requirements

Excellent written & oral communication skills. Computer literate.

• Work independently, effectively & flexibly as part of a team-unit. Cooperate in the accomplishment of departmental goals/organisational objectives

About us

Trust mission

To be the leading national and international centre for the diagnosis, treatment and care of patients with heart and lung disease, creating and disseminating knowledge through research and education

Job description

Job responsibilities

Patient care

Your primary concern will be to maintain patient safety during the conduct of clinical studies. The post holder will be responsible for:

• Coordination and facilitation of clinical research projects, managing them to the relevant standards.
• Screening of case notes for recruitment of appropriate candidates and discussing with patients about the opportunity to join a relevant study.
• Coordinating and supporting medical, nursing and technical staff to successfully complete research projects and the execution of clinical trials
• Participation in the execution of clinical studies taking patient samples, testing prototype medical equipment, performing analysis on patient samples
• Facilitating the research study process including scheduling patient admissions and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocolBeing the point of contact for study participants, giving advice on the relevant study and correlated health issues
• Ensuring that nursing/ multidisciplinary team (MDT) documentation is maintained to the Trust and GCP standards
• Introducing improved systems of research conduct and management to enable successful project delivery
• Ordering and purchase of equipment using online systems including interaction with University based staff and systems
• Trust-wide clinical research polices and protocols, insuring their implementation
• Analyse research data, ensuring consistency and accuracy. Identify key errors in data collection/entry and address or flag as necessaryIdentify system errors in bespoke data management systems (e.g. electronic case report forms) and provide feedback to the respective team and study nurse
• Address recurrent data queries which may highlight system problems or data collection issues
• Assist with ensuring that study equipment has the ability to download information as required by the study protocol

During research visits, specific duties will include, although not exclusively consist of:

• Height and weight measurements
• Collection of vital signs
• Recording adverse events and changes in medication
• Performing lung function, ECGs and sweat tests
• Sputum induction and sample collection
• Collection of breath samples
• Obtain blood samples by venesection
• Administration of Quality of Life questionnaires
• Supervision of study drug dosing

Training will be provided as needed in all of the above procedures.

Communication

• Arranging and attending team meetings
• Writing and circulating summaries of monthly meetings as requested
• Have an active email account and share information appropriately
• Document all adverse incidents as required by study protocols
• Report to local, national and international project partners as required
• Report on the technical and clinical performance of the studies as required
• Participate in local, national and international meetings

People management

Coordinate the participation of nursing, practitioner and medical staff to ensure the trials are completed within the project timetable

Ensure that they themselves and others involved in a study have the correct training to undertake the procedures. Ensuring that they and the team are up to date with their mandatory training

Organise own work on an ongoing basis, arranging one-off or recurring events, including training, Site Initiation Visits and Monitoring Visits

Policy and Service Development

You will be responsible for maintaining trial data to the relevant standards required for the study. This will include:

• Maintaining Trial Master Files to Medicines and Health Regulatory Authority (MHRA) standards
• Maintaining Investigator Site Files
• Collating source data
• Electronic reporting of trial data
• Checking, filing and monitoring patient consent forms
• Creating systems for data gathering and trial conduct such as standard operating procedures (SOPs)
• Entering data onto database
• Aiding statistical analysis
• Implement the trust policies & protocols within the department

In conjunction with the lead investigator for each project and/or the senior team, you will assist with writing and make available all SOPs, policies and guidance notes that will be needed by the research team to ensure the safe conduct of the clinical trials. Trial SOPs will conform to all relevant Policies such as Infection Control, Data Protection, Human Tissue Act.

Resource management

• Manage an inventory of consumables and equipment required for specific studies
• Record the use of any materials expended by the group in the conduct of the trials
• Purchase any additional equipment needed to conduct trials
• Report expenditure accrued in the conduct of clinical trials
• Arrange reimbursement of expenses to patients participating in research studies
• To attend relevant meetings
• To undertake any necessary training and/or development

Information management

Further sections

• To ensure all mandatory training courses such as Manual handling, Fire, Resuscitation, health and safety are attended on an annual basis and the knowledge gained adhered to.
• To abide by the Trusts core behaviours for staff and all other Trust policies including standing financial instructions, research governance, clinical governance, patient and public involvement, codes and practices, and health and safety policies
• This job description is intended as a basic guide to the scope and responsibilities of the post and is not exhaustive. It will be subject to regular review and amendment as necessary in consultation with the post holder.

Person Specification

EDUCATION & QUALIFICATIONS

Essential

• Educated to degree level in a healthcare or science related subject or Professional Nursing Qualification with valid NMC registration

Desirable

• Post graduate training in respiratory medicine
• A strong academic track record.
• CRP accreditation

EXPERIENCE & KNOWLEDGE

Essential

• Experience of working directly with patients / study participants in a clinical setting
• Proven experience of accurate data management
• Logical and consistent work and career pattern.
• Interest in Clinical Research

Desirable

• Substantial and proven relevant clinical research experience in pharmaceuticals, CROs or academic clinical trial units
• Knowledge of Research Governance Framework (RGF), International Conference on Harmonisation/Good Clinical Practice (ICH/GCP)
• Experience of working with children, preferably in a clinical setting
• Direct experience of working with source data and electronic data capture systems for clinical research

SKILLS & ABILITIES

Essential

• Ability to communicate well both orally & in writing
• Able to work under pressure with patients with complex medical conditions
• Advanced computer literacy
• Ability to perform dextrous and complex tasks with precision
• Good time management & organisation skills
• Able to work effectively as part of a multi- disciplinary team
• Advocacy for children
• Ability to recognize own limitations

PERSONAL QUALITIES

Essential

• Good interpersonal skills
• A commitment to sharing knowledge
• Enjoy working with other health professionals
• Dynamic, enthusiastic and forward looking
• Flexible approach to working practices

OTHER REQUIREMENTS

Essential

• Reliable work record
• Able to safely move & handle patients & equipment

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Royal Brompton Hospital

London

SW3 6NP

Any attachments will be accessible after you click to apply.

196-RD161