Clinical Research Practitioner or Clinical Research Nurse

Job description

Job responsibilities

This post is to work within the Imperial College/Royal Brompton cystic fibrosis (CF) clinical trials group comprising clinicians, academics, allied health professionals and admin/ finance members. The Brompton adult and paediatric CF centres are made up of world leading teams undertaking trials seeking improved treatment for adults and children with CF. The team is part of the UK CF Trust Clinical Trials Accelerator Platform (CTAP; https://www.cysticfibrosis.org.uk/the-work-we-do/clinical-trials-accelerator-platform) and the European CF Society Clinical Trials Network (https://www.ecfs.eu/ctn). Both initiatives provide opportunities for our patients to participate in trials of new, cutting-edge medicines.

The post holder will assist the team on global, multicentre interventional and observational studies, in both adults and children, being led by Profs Davies, Simmonds and colleagues. You will be primarily responsible for all matters relating to clinical trial data collection and management, involving direct patient interactions and provision of administrative support for trial-related activities. This role requires the post holder to be able to handle a varied and extensive workload. Training will be provided in all aspects of the role.

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

Clinical research:

Coordination and facilitation of multiple clinical research projects across a range of disease areas and, managing them to the relevant standards

Introducing improved systems of research conduct and management to enable successful project delivery

Recruiting patients and volunteers (adults and children) into clinical trials

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

Ordering and purchase of equipment using online systems including interaction with University based staff and systems

Being aware of Trust-wide clinical research polices and protocols, ensuring their implementation

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 testing, ECGs and sweat tests

Sputum induction and sample collection

Collection of breath samples

Obtain blood samples by venesection (once trained)

Administration of Quality of Life questionnaires

Co-supervision of study drug dosing

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

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

Screening of case notes for appropriate candidates for the relevant studies and discussing with patients about the opportunity to join a relevant study.

Facilitating the research study process including scheduling patient admissions and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocol.

Being 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.

Technical Duties and Services

With respect to analysis of research data you will:

Enter research data, ensuring consistency and accuracy.

Identify key errors in data collection/entry and address or flag as necessary

Identify 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

Work with sponsors throughout the full duration of the trial

Attend relevant meetings, presenting and taking minutes when required

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

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.

In addition you will :

Undertake relevant training for electronic information systems in place & under development.

Maintain an active awareness of developments in clinical research related laws, and suggest changes in response.

Draft new processes or procedures for approval within your work remit.

Participate in the collection and discussion of audit and research data as required.

All data gathering and reporting activities must comply with the provisions of the Data Protection Act 1998. Patient identifiable data must be maintained according to the relevant Trust policy on confidentiality and data security.

People Management

You will:

• Coordinate the participation of nursing 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

Communication

You are expected to be one of the central points of contact for the studies they are involved in; these parties may be internal or external, industrial or academic. At all times the post-holder must present a professional image and promote the College & Trusts research strategy.

You will facilitate communication across the group by:

Arranging and attending team meetings

Writing and circulating summaries of monthly meetings as requested

Have an active email account and share information appropriately

You will also be responsible for reporting untoward incidents that may compromise patient safety and any other relevant information to a registered doctor or nurse immediately including:

• 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

You will participate fully as a multi-disciplinary team member, sharing knowledge and information and supporting colleagues, to promote a cohesive team and the achievement of team objectives.

At all times you will demonstrate a courteous and helpful approach to patients, relatives and visitors in the clinical area within their own capabilities; promoting the corporate image of the Trust to all individuals, groups and organisations, both within the Trust and externally to the community at large.

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

Other

• To attend relevant meetings
• To undertake any necessary training and/or development

Person Specification

Qualifications

Essential

• - You must be Educated to degree level in a healthcare or science-related subject or Professional Nursing Qualification with valid NMC registration
• - Experience of working directly with patients / study participants in a clinical setting is essential and experience of working with children is desirable
• - A good understanding of clinical terminology is required, and ideally in respiratory physiology
• - You must have proven experience of organisational, record keeping, and time management skills, accurate data management, knowledge of handling confidential information and an understanding of current legislation and requirements
• - Excellent written and oral communication skills and computer literacy are essential
• - You must have the ability to work independently, effectively and flexibly as part of a team-unit and cooperate in the accomplishment of departmental goals and organisational objectives

Experience

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.

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).

Employer details

Employer name

Imperial College London

Address

Royal Brompton Campus

London

SW3 6NP

Employer's website

https://www.imperial.ac.uk/ (Opens in a new tab)