Senior Clinical Trials Assistant (XN04)

Integrated Care System; Leeds; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading healthcare system is seeking a B4 Senior Clinical Trials Assistant to support clinical research within their Oncology GI/Germ Cell and Sarcoma research team. This full-time role involves coordinating clinical trials, assisting in administrative tasks, and ensuring compliance with all research protocols while maintaining high standards of patient care. The position provides an opportunity to contribute to innovative research that enhances patient outcomes.

Qualifications

• Experience in clinical trials and administrative settings.
• Understanding of NHS and research methodologies.
• Good Clinical Practice (GCP) training preferred.

Responsibilities

• Assist with clinical trials management including costings and trial setup.
• Collect and process biological samples according to trial protocols.
• Interface with patients for informed consent and maintain research data.

Skills

Good communicator

Attention to detail

Teamwork

Education

NVQ level 3 or equivalent

Job description

TheOncology GI/Germ Cell and Sarcoma Research Team is recruiting!

TheResearch and Innovation Department is continuing its exciting expansion. Wehave several research specialities and the Oncology GI/Germ Cell and Sarcomaresearch portfolio is looking for a B4 Senior Clinical Trials Assistant. Itis a full time post (1.0 WTE), with a permanent contract. This post will bebased at SJUH.

Thepost holder will contribute actively to the conduct, coordination, anddelivery of the GI/GC and Sarcoma Research Portfolio. The main tasks are:Assisting with administrative aspects of clinical research/trials managementincluding costings, trial set up and data input, also assisting the ResearchNurses with their clinical and administrative duties, and managing their ownportfolio of studies. In addition to being responsible for ensuring that highstandards of clinical care planning, delivery, safety, and patientsatisfaction are to a very high standards, compliance with Trust policy,study protocol requirements, local and national guidance and legislation isrequired

Ifyou are interested in the post, we would like to encourage you to contact therecruiting manager for an informal discussion.

Main duties of the job

Weare looking to recruit a proactive and self-motivated individual with a keeninterest in research to work within the GI/GC and Sarcoma team.

Thepost holder will be required to work alongside industry partners, theNational 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, working within a busyClinical research department with a large portfolio of studies covering arange of conditions. Studies include those funded by the NIHR/RDN, commercialtrials, academic studies and early phase (experimental) therapies.

Thepost holder is expected to meet all reporting procedure timescales andinternational, national and local standards for clinical trial governance.

Thepost holder will be required to undertake some clinical skills e.g. clinicalobservations, venepuncture and taking of electrocardiographs (ECG). This willbe as directed by the Senior Research Nurses and training will be given.

Thepostholder will also be expected to;

Assist in the co-ordination of the patients journey through the clinicaltrial protocol e.g. requisition and organisation of any necessaryinvestigations, procurement of patient notes.

Assist in the collecting, processing, packaging and dispatch of biologicalsamples in accordance with trials protocols.

About us

Researchis at the heart of our Trust. Leeds Teaching Hospitals is involved inresearch at all levels, developing and trialling new treatments for patients.We believe that being involved in cutting-edge research helps us providebetter care to our patients.

Overthe next 5 years, we aim to be the best Trust to deliver high-qualityclinical research and to champion research amongst our staff. We also aim tosupport and grow our world-class clinical infrastructure and assets forresearch and innovation.

Wehave a very proactive Research Academy. It offers an extensive programme ofeducation and training tailored to meet the needs of individuals, teamsinvolved in clinical research delivery in Health and Social Care.

Ourfive Trust values are part of what make us different. They have beendeveloped by our staff. They are:

-Accountable

-Empowered

LeedsTeaching Hospitals is committed to our process of redeploying 'at risk'members of our existing workforce to new roles. As such, all our job advertsare subject to this policy and we reserve the right to close, delay or removeadverts while this process is completed. If you do experience a delay in theshortlisting stage of the recruitment cycle, please bear with us while thisprocess is completed, and contact the named contact if you have anyquestions.

Job responsibilities

Thepost-holder is responsible for supporting and administering all clinical research within Research and Innovation atLeeds Teaching Hospitals NHS Trust under the guidance of the Senior ResearchNurse/Midwife/ AHP/AHCS

Thepost-holder must ensure that all trial protocols are adhered to in line withICH-GCP practice. The post-holder will act as Assistant to the SeniorResearch Nurse/Midwife//AHP/AHCS and will liaise with all internal andexternal parties involved in the setting up, maintenance and closure ofresearch studies. The post-holder will assist with administrative aspects ofclinical research/trials management including costings.

Thepost holder may be expected to interact with patients and their families inrelation to the requirements of the research study and be able to workwithout supervision in some areas. A key component of the post is to carryout the informed consent process with patients as appropriate and followingspecific training and administer the necessary paperwork and maintaining aclear audit trail. You will have responsibility for logging all patients intothe EDGE research database and departmental clinical trials database ensuringinformation is

accurateand up-to-date. Your role may also include some clinical skills such astaking clinical observations, venepuncture, cannulation, takingelectrocardiography (ECG) tracings and processing clinical samples as agreedwith manager and where appropriate with adequate documented training.

Person Specification

Experience

• Previous administrative experience
• Clinical trials experience
• Experience working in NHS having direct or indirect 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

Additional Requirements

• Willing to undergo training as required
• Good Clinical Practice (GCP) training
• Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary),

Qualifications

• Good standard of education NVQ level 3 or equivalent
• AHCS registered
• NHS Care Certificate

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, cannulation, ECG

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.