An exciting opportunity has arisen for an enthusiastic and motivated Band 4 Senior Clinical Trials Assistant to join the Children's Research Team within Research and Innovation (R&I). We are looking for a dynamic and motivated individual who will help support the delivery of a high-quality service that enhances patient safety and experience whilst participating in clinical research.
Specifically, this post will be to support the portfolio of Children's Oncology/Hematology studies and clinical trials based at the Leeds Children's Hospital. The department supports and facilitates a wide variety of clinical trials and aims to achieve the best clinical outcomes through the delivery of robust and innovative research for children and young people of all ages.
The post holder will undertake a range of duties and can be expected to work autonomously when required or under the supervision of the Senior Research Nurse. The role will provide an ideal opportunity to develop your knowledge of different phases of clinical trials, the research process, and how patients/participants and their families/carers are central to everything we do.
Leeds Teaching Hospitals research delivery teams are involved in research into advanced therapies and new novel biological treatments as well as those of existing medicinal products and medical devices. We also run studies involving the collection of biological samples and observational data collection studies.
Main duties of the job
The post holder will be responsible for assisting with the collection and processing of clinical trials data and data management. The role may include direct involvement with patients and families, recruiting for trials, delivering clinical care, and performing clinical assessments whilst ensuring trials are conducted in accordance with current Governance and Regulatory requirements. The successful applicant will perform both clinical and administrative roles, so knowledge of nursing care and computer systems is essential. Phlebotomy skills may also be required in certain departments, but training can be given.
The post-holder will act as Assistant to the Senior Research Nurse/Midwife/researcher and will liaise with all internal and external parties involved in the setting up, maintenance, and closure of research studies. The post holder will assist with administrative aspects of clinical research/trials management including costings.
The post holder will be involved in raising awareness and embedding research within LTHT and offering people opportunities to take part in research as part of their standard care pathway.
They will act as a member of the multidisciplinary team, advising and supporting the clinical teams with research-related matters and will also maintain their clinical skills.
About us
Expected Shortlisting Date: 16/01/2025
Planned Interview Date: 03/02/2025
Research is at the heart of our Trust. LTHT is involved in research at all levels, developing and trialling new treatments for patients. We believe that being involved in cutting-edge research helps us provide better care to our patients.
Over the next 5 years, we aim to be the best Trust to deliver high-quality clinical research and to champion research amongst our staff. We also aim to support and grow our world-class clinical infrastructure and assets for research and innovation.
We have a very proactive Research Academy. It offers an extensive programme of education and training tailored to meet the needs of individuals and teams involved in clinical research delivery in Health and Social Care.
Job responsibilities
The post holder will have an understanding of the principles of clinical research and be expected to develop a working knowledge of clinical research. The post holder will have the ability to comply with ICH GCP guidelines for clinical research as well as the LTH Trust guidelines and policies. The post holder will be familiar with the process of clinical trials and be willing to undergo further training as required to gain the knowledge shortly after entering the post.
PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY
Patient support;
To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the coordination of tests, obtaining results, and arranging transport and documentation of specific specimens as per clinical trial protocols.
Assist the Senior Research Nurse in the development of systems and procedures for safe trials operations i.e. adverse event reporting, updating protocols, communication of revisions etc. to ensure safe operation of the trials in line with ICH-GCP standards.
In order to ensure requirements are being met regarding patients entering trials, you will collect data using case notes, diagnostic reports, and liaison with third parties, using tact and negotiating skills, for the purpose of completing datasets on each trial's patient as required.
Clinical Research;
The post-holder will be responsible for specific aspects of trials, including the obtaining of informed consent, where there may be barriers to understanding, as appropriate and as directed by the Senior Research Nurse/Midwife (training will be given).
The post holder may be required to undertake some clinical skills e.g. clinical observations, venepuncture, or taking of electrocardiographs (ECG). This will be as directed by the Senior Research Nurse/Midwife and training will be given.
To assist the coordination of the patient's journey through the clinical trial protocol e.g. requisition and organization of any necessary investigations, procurement of patient notes.
Assist in the collecting, processing, packaging, and dispatch of biological samples in accordance with trials protocols.
Team Working;
To ensure that all members of the multidisciplinary team are aware of the current trials portfolio; status of studies, and any trial amendments.
To provide feedback to MDT members on issues relating to recruitment, protocol amendments, and trial results.
To disseminate information from Senior Research Nurse/Midwife to the MDT.
Attend meetings as required by the Senior Research Nurse/Midwife and report back on findings to the rest of the team.
The post holder will demonstrate the ability to manage their own caseload, working as part of the multidisciplinary team.
In conjunction with all members of the research team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service.
Assist the Senior Research Nurse/Midwife in the day-to-day operations of the Trials department helping other team members who are new to the department as required.
Administration;
Assist the Senior Research Nurse/Midwife with the preparation of documentation for submission to regulatory authorities and follow up on the progress of each trial submitted.
To coordinate the maintenance of all documentation required in site files, including archiving arrangements.
The post holder will be responsible for ensuring that all routine documentation is processed, copied, filed, and archived as appropriate where the post-holder is responsible for a particular trial in progress.
To assist with the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.
To ensure that all data entry is compliant with protocol requirements.
To ensure that all trial data is submitted to the study sponsor within the specified time constraints.
To manage and respond to any data queries received.
To ensure timely entry of recruitment figures to the EDGE database, and all other relevant databases, ensuring information is accurate and up to date.
To report monthly to the Senior Research Nurse/Midwife accrual data on all patients recruited into the study portfolio highlighting local activities that might impact on the achievement of the department's research aims.
Liaise with external companies, sponsors, and regulatory authorities to address any queries resulting from trials in progress.
Assist the Senior Research Nurse/Midwife in the preparation of financial reports for trial meetings and track departmental financial income and liaise with the Finance department as required.
The post-holder will assist the Senior Research Nurse/Midwife in the preparation of Trials audits which are undertaken by external agencies, ensuring that everything required is made available to the auditors when they arrive on site.
Maintain an agreed level of supplies required across the clinical trials team and complete orders in line with departmental requirements.
General;
To contribute to the development of the portfolio of trials.
To help implement local and national and international quality standards, professional standards, recommendations, and guidelines from national reports.
The post holder will adhere to the Data Protection Act and maintain patient confidentiality at all times.
The post holder will act in a professional manner at all times when dealing with patients, their relatives, and representatives from both external and internal sources.
The post holder will deal with telephone enquiries from staff, patients, and carers ensuring that appropriate personnel are informed in order for actions to be taken.
The post holder will be expected to represent the research team in a professional manner at meetings and events.
The post holder will be expected to work to ICH GCP guidelines at all times.
As a new post holder, an induction and training programme will be provided for key aspects of this role, however, the post holder will be expected to take advantage of opportunities to attend meetings and workshops to enhance their knowledge of Clinical Research and patient care.
The staff member will ensure that (s)he follows the Trust's hospital infection prevention and control policies and procedures to protect patients, staff, and visitors from healthcare-associated infections. He or she will ensure that (s)he performs the correct hand hygiene procedures when entering clinical areas.
To undertake any other duties deemed appropriate to the role, including interaction with patients and families when this is deemed appropriate.
Person Specification
Other Criteria
* Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary)
* Willing to undergo training as required
* Good Clinical Practice (GCP) training
Qualifications
* Good standard of education NVQ level 3 or equivalent
Skills & behaviours
* Good communicator and use of initiative.
* Able to work on own or as part of a team
* Able to work on own initiative/proactive approach
* Honest and fair approach when dealing with work, colleagues, and the team
* Must be able to deal with the public and staff in a pleasant and polite manner at all times.
* Good interpersonal skills
* Effectively communicate with multidisciplinary team members
* Ability to pay attention to detail
* Previous clinical skills training e.g. taking clinical observations, venepuncture, ECG
Experience
* Previous administrative experience
* Clinical trials experience
* Experience working in NHS having contact with patients in either a clinical or research setting
* Knowledge of research methodologies
* Understanding of the NHS and the organisation
* Previous experience of working within Clinical Trials Management within the NHS
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.
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