Clinical Research Assistant Leicester, England
Job description
This is a unique and exciting opportunity for a clinical research expert to join the Research & Innovation (R&I) workforce at University Hospitals of Leicester.
This is a great opportunity to become a member of the HOPE cancer trials team. We have an ever changing diverse portfolio of clinical haematology and oncology trials including those exploring compounds at the early stages of development. We offer a commitment to support training and professional development needs and the opportunity to develop interests and skills in the prevention, diagnosis and treatment of cancer.
There are close relationships between the BRC Themes, University of Leicester and UHL clinical areas across the 3 sites. Funding from the Clinical Research Network (CRN) will support the delivery of research programmes across all specialties at UHL.
The appointee’s main responsibilities include collecting, recording and maintaining data for patients and volunteers on research studies. To support research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.
To provide clinical support to patients in clinical trials such as taking samples, performing tests and physical measurements in accordance with the clinical trial protocol and Good Clinical Practice (GCP). To ensure compliance with UHL policies on data protection, confidentiality and security.
The post holder will provide the highest standards of patient care in line with research protocols and will ensure that such research safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice guidelines for research.
To work alongside Principle Investigators and the research team to assist in the delivery of a high quality research service of clinical expertise, professional advice, support, guidance and education to the multi-professional team, patients and carers within the research service.
The post-holder will ensure the highest standard of care is delivered to research subjects and, where relevant to their families, in partnership with all members of the multi professional and research teams.
We are one of the biggest and busiest NHS trusts in the country, incorporating the General, Glenfield and Royal Infirmary hospitals. We have our very own Children’s Hospital and run one of the country’s leading heart centres.
Our team is made up of more than 17,000 staff providing a range of services primarily for the one million residents of Leicester, Leicestershire and Rutland.
We work with partners at the University of Leicester and De Montfort University providing world-class teaching to nurture and develop the next generation of doctors, nurses and other healthcare professionals, many of whom go on to spend their working lives with us.
Our purpose is to provide ‘Caring at its best’ and our staff have helped us create a set of values that embody who we are and what we’re here to do. They are:
We focus on what matters most
We treat others how we would like to be treated
We are passionate and creative in our work
We do what we say we are going to do
We are one team and we are best when we work together
Our patients are at the heart of all we do and we believe that ‘Caring at its best’ is not just about the treatments and services we provide, but about giving our patients the best possible experience.
About the University Hospitals of Leicester NHS Trust (leicestershospitals.nhs.uk
The appointee will be required to process biological samples.
The post holder should be adaptable, flexible and show initiative. In addition they need to show good communication skills, be able to liaise with all levels of staff, demonstrate good organisational skills and attention to detail, have good time management skills and be flexible as the working hours may not be fixed.
The post-holder will be allocated to a specific research clinical area.Travelling across UHL 3 sites (Leicester Royal Infirmary, Leicester General Hospital and Glenfield Hospital) will be required.
Opportunities to develop expertise in other research specialties will be available. The post-holder may be required to work in other research areas across UHL if service needs arise.
This post may involve shift patterns, including internal rotation onto night duty to ensure 24 hour cover (including bank holidays).
WORKING RELATIONSHIPS
To develop and maintain constructive working relationship with muti-professional teams within the speciality. Have some responsibility for ensuring good communication between all service providers within the speciality. Actively participate in local and national networking groups to develop an expert level of knowledge in the speciality.
KEY WORKING RELATIONSHIPS
Clinicians
Physicians
Research Scientists
Site Lead Research Manager
BRC Theme Clinical Manager
BRC Theme Operations Manager
Research Nurse /research assistants/study support team
Research Champions
Acute care wards and teams associated with these wards
Patients/Carers
Other Clinical/Research Groups
COMMUNICATION
Good communication skills will be paramount to this position with the involvement of working across clinical business units to include physicians, MDT, research scientists, patients and carers.
KEY RESULT AREAS
1. To assist with the acquisition and distribution of relevant trial documentation.
1. To assist with the acquisition and distribution of study equipment/tools and ensure relevant health and safety checks are carried out in accordance with relevant Trust Policies.
1. To assist in the preparation and submission of documentation for clinical research approvals.
1. To create and maintain trial site files for each trial in accordance with ICH-GCP and Research Governance.
1. Collection of patient data from medical notes and completion of case record form (CRF) and to liaise with clinical trials coordinators, research nurses and investigators to ensure accurate data collection.
1. To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic e-CRFs) as required by the study protocol.
1. To ensure safe filing and storage of study documentation in accordance to research governance.
1. Conduct quality assurance of documentation.
1. To organise and prepare for visits by trial monitors as required by the study protocol.
1. To take responsibility for liaising with clinical trial units regarding data queries and for checking and resolving data queries.
1. To evaluate patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocol.
1. Demonstrates commitment to the role of patient advocate for patients considering or participating in clinical trials.
1. To provide written and verbal information relevant to the research study and gain informed consent from participants for entering into clinical research, where the necessary approvals are in place to do so.
1. To deal with telephone enquiries from staff, patients and relatives, ensuring that appropriate personnel are informed in order for actions to be taken.
1. To report any adverse events to the appropriate research nurse and/or principal investigator (PI).
1. Presenting specific trial information at multidisciplinary team meetings.
1. To act in a professional manner at all times when dealing with patients, relatives and representatives from both within and outside of the Trust.
1. Co-ordination of specified trials and take responsibility for : • Organisation of any necessary tests and investigations as detailed within the
- Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.
- Undertaking low risk clinical duties
- Maintaining logs of stored samples and freezer temperatures.
- Maintaining adequate stock levels of sample kits.
- Required to hold a phone for a short period of time to monitor freezer/fridge temperatures including during and out of office hours.
- Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice.
- Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments.
- Resolving data queries raised by sponsoring organisations.
- Archiving all study related material including patient’s notes after study closure.
- Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office.
- Tracking Serious Unexpected Event reporting
- Maintaining and updating study specific site files.
- Notifying General Practitioners of their patient’s involvement in a clinical trial.
- As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge.
All employees are subject to the requirements of the Health & Safety at Work Act. The post holder is required to ensure that as an employee, his or her work methods do not endanger other people or themselves.
All employees are subject to the requirements of the Data Protection Act and must maintain strict confidentiality in respect of patient’s and staff’s records.
All employees must comply with the Trust’s Equal Opportunities Policy and must not discriminate on grounds of age, colour, race, nationality or ethnic origin, religion, belief, gender, marital status, sexuality, disability, trades union membership (or non-membership) or political affiliation, or any other grounds which cannot be shown to be justifiable.
This job description is not to be taken as an exhaustive list of duties and it may be reviewed in the light of changed service needs and development.
Any changes will be fully discussed with the post holder. The post holder will be required to carry out the duties appropriate to the grade and scope of the post.
In order to ensure the Trust’s ability to respond to changes in the needs of the service, after appropriate consultation anddiscussion with you(including consideration of personal circumstances current skills, abilities and career development) the Trust may make a change to your location, duties and responsibilities that are deemed reasonable in the circumstances.
Your normal place of work will be as discussed at interview and will be confirmed in Section 1 of your contract but you may be required to work in other locations of the Trust. In particular, flexibility is required across the three main Hospital sites (Leicester Royal Infirmary, Leicester General Hospital, Glenfield Hospital). If your initial location is based at one of these sites, excess travel reimbursement will not apply for a permanent/temporary change to base.
