Senior Clinical Trials Assistant (XN04)

Job description

Job responsibilities

JOB DETAILS

Job Title: Senior Clinical Trials Assistant

Reports to: Senior Research Nurse/Midwife

Accountable to: Senior Research Nurse/Midwife

Band: 4

Unit/Department: Research & Innovation

Directorate: Research & Innovation

Location : Leeds General Infirmary, St Jamess University Hospital & Lung Screening Mobile Unit

AfC Number: 2926

2. JOB PURPOSE

The post-holder is responsible for supporting and administering all clinical research within Research and Innovation at Leeds Teaching Hospitals NHS Trust under the guidance of the Senior Research Nurse/Midwife/researcher.

The post-holder must ensure that all trial protocols are adhered to in line with ICH-GCP practice. 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 may be expected to interact with patients and their families in relation to the requirements of the research study and be able to work without supervision in some areas. A key component of the post is to carry out the informed consent process with patients as appropriate and following specific training, and administer the necessary paperwork and maintaining a clear audit trail. You will have responsibility for logging of all patients into the EDGE research database and departmental clinical trials database ensuring information is accurate and up-to-date. Your role may also include some clinical skills such as taking clinical observations, venepuncture, taking electrocardiography (ECG) tracings and processing clinical samples.

3. JOB DIMENSIONS

The post holder will be working within a busy Clinical research department with a large portfolio of studies covering a range of conditions. Studies include those funded by the NIHR, commercial trails, academic studies and early phase (experimental) therapies. Clinical trials support is provided to the research team and the numbers of patients in trials can range from 1 to 50+. The post holder is expected to meet all reporting procedure timescales and international, national and local standards for clinical trial governance.

The post holder will be required to work alongside academic and industry partners, the National Institute for Health Research (NIHR) Clinical Research Network (CRN) Yorkshire and Humber (Y&H) and colleagues in neighbouring establishments, attending regional and national meetings as required.

This post will be part of a team supporting the Yorkshire Lung Screening Trial (YLST), the largest UK randomised trial of computed tomography (CT) screening for lung cancer. Due to the unique nature of this post there will be some time spent working in a mobile screening unit and some office based.

The office base will be within the chest clinic at Leeds General Infirmary. Office based duties include telephone screening of potentially eligible participants and following up study queries.

The mobile unit will be based in supermarket car parks around the Leeds area and will see invited, eligible participants for consenting, lung health checks and CT screening for lung cancer. The team on the mobile will consist of the research delivery team (research nurses and clinical trials assistants), smoking cessation staff and radiographers. Following full study specific training your duties may include receiving informed consent, undertaking spirometry and obtaining blood samples.

4. ORGANISATIONAL CHART

5. KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED

Qualifications

Literate and numerate

Good standard of education to a minimum of NVQ level 3 or equivalent

Experience

Previous administrative experience

Clinical trials experience

Experience working in the NHS having contact with patients in either a clinical or research setting

Informed consent experience (desirable)

Training

Willing to undergo training as required

Good Clinical Practice (GCP) training

Specialist Knowledge

Insight into role and responsibilities of post

Knowledge of research methodologies

Understanding of the NHS

Disposition/Attitude

Able to work as part of a multidisciplinary team

Committed to working with people

Good communicator

Able to work on own using own initiative

Practical Skills

Good interpersonal skills

Excellent IT skills

Effectively communicate with multidisciplinary team members

Ability to pay attention to detail

Time management skills

Previous clinical skills training e.g. taking clinical observations, venepuncture or taking ECGs (desirable but not essential)

Person Specification

Skills & Behaviours

Essential

• Excellent IT skills
• Good interpersonal skills
• Effectively communicate with multidisciplinary team members
• Ability to pay attention to detail
• Time management skills
• 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

Desirable

• Previous clinical skills training e.g. taking clinical observations, venepuncture, ECG

Experience

Essential

• Previous administrative experience
• Clinical trials experience
• Experience working in NHS having contact with patients in either a clinical or research setting
• Willing to undergo training as required
• Good Clinical Practice (GCP) training
• Knowledge of research methodologies
• Understanding of the NHS and the organisation

Desirable

• Previous experience of working within Clinical Trials Management within the NHS
• Informed consent experience

Qualifications

Essential

• Good standard of education NVQ level 3 or equivalent

practical skills or Additional Requirements

Essential

• Good health/reliable attendance
• Smart appearance

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.

Employer details

Employer name

Leeds Teaching Hospitals

Address

St. James's University Hospital

Beckett Street

Leeds

LS9 7TF

Employer's website

https://www.leedsth.nhs.uk/ (Opens in a new tab)