Clinical Trials Assistant

The Mid Yorkshire Teaching NHS Trust; Wakefield; On-site; GBP 25,000 - 35,000; Full time

Job description

Job summary

Are you looking for a rewarding career in Research?

We are delighted to be offering a full time post, to suitable candidates wishing to start or develop their skills and practice in Clinical Research.

We have a team of around 54 staff including Research Nurses, AHP's, Research Governance and Research Administrative staff, working together to ensure that research is considered as part of patient care options for all eligible patients and ensure that research opportunities are available to our patients.

Working in Clinical Research, you will join an enthusiastic, driven, and caring research team, to help provide support to our research team, for new and existing studies. Our team participates in research within many different specialities across the Trust. There are always opportunities to gain knowledge and experience within a number of these specialities. Clinical research experience is not essential for the role, full research training will be given; we have an excellent induction and ongoing education programme.

Main duties of the job

The post holder will assist with the delivery of direct and indirect clinical and research care in support of research studies within the acute care team which covers a number of disease areas. The post holder will assist with the general administrative requirements associated with study set up, running and closing of a clinical trial including data collection, data entry maintenance of essential documents. All work undertaken in the Department, is in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP) to ensure provision of high-quality care.

The post holder will carry out assigned administrative and clinical duties under direct and indirect supervision of senior nursing staff other relevant professional practitioners to provide, through Divisional policies, a safe environment for the treatment of research subjects, and the protection of staff. They will also support data management for all aspects of trial organisation, as an integrated member of the research team, and will also be expected to interact with patients and their families in relation to the clinical trial and be able to work without supervision.

About us

We are an acute trust caring for over half a million people in Wakefield and Kirklees. Our 10,000 staff work in patients homes, the community, and our three hospitals in Pontefract, Dewsbury, and Pinderfields. We prioritise our people and values so we can deliver the best possible care to patients. Our team is friendly, passionate, and innovative, always seeking better ways to work.

We support work-life balance and foster a diverse, inclusive environment where everyone belongs. Our staff networks offer safe spaces to share ideas and concerns so we can increase awareness and appreciation of equality, diversity, and inclusion. We welcome applicants from all backgrounds and especially encourage members of the LGBTQ+ community, ethnic minority groups, and people with disabilities or neurodivergence to apply, as they are currently underrepresented in the Trust.

Application guidance: We understand that more applicants are using AI technology to help with their applications. While these tools can be useful, they cannot fully capture your skills, knowledge, and experience. It's important that you personalise your application. Relying solely on AI is not recommended, as it may reduce your chances of success. Our screening process is thorough, so if you have used AI, please make sure to disclose this on your application form.

If sufficient applications are received, the advert may close earlier than the planned closing date. We encourage you to submit your application as soon as possible.

Job description

Job responsibilities

• To assist in the identification of patient eligibility for studies/trials.
• Liaise with other appropriate health care professionals.
• To assist with the co-ordination of the patients journey through the clinical trial protocol e.g., requisition and organisation of any necessary investigations.
• To use resources effectively by prioritising daily caseload to maximise the benefit to patients.
• To undertake clinical duties and non-clinical duties as directed by a qualified health care professional.
• To undertake frequent therapeutic handling and moving of patients with aids (as needed) and equipment utilising moderate physical effort within clinical and non-clinical settings. This may involve bending, kneeling or frequent repetitive activities often in confined spaces.
• To ensure that all members of the multidisciplinary team are aware of the current trials portfolio.
• To provide feedback to Clinical teams on issues relating to recruitment, protocol amendments and trial results.
• The post holder will demonstrate the ability to manage their own administrative caseload, working as part of the team.
• In conjunction with all members of the clinical trials team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the service. To assist the research teams in the formulation of documentation in preparation for ethical submission and R&D submission.
• To assist the research team in setting up new studies/trials, ensuring site files are maintained in accordance with ICH GCP.
• To be responsible for the collection and collation of trial data and completion of trial documentation in accordance with trial protocols.
• To ensure that all quality-of-life assessments are completed in line with protocol requests. This may involve undertaking telephone assessments.
• 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 maintain a monthly accrual list of all studies and distribute among the relevant members of the MDTs.
• To report monthly accrual data on all patients recruited into studies highlighting local activities that might impact on achievement of targets.
• To ensure all accrual data is inputted onto the recruitment database/electronic systems.
• To be responsible for monitoring and ordering specific trial equipment and stationary.
• To assist in the planning and organising study feasibility meetings and site initiation meetings, involving internal and external teams.
• To take minutes and maintain documentation during trial management meetings or other related meetings.
• To assist in the writing of standard operating procedures.
• To clearly communicate timely, accurate and relevant information regarding patient care with patients, their families and carers, other professionals and services, to ensure seamless, quality care and to empower patients to become partners in their care.
• To maintain standards in organising health information, to safeguard the confidentiality of patient information, be aware and comply with policies, practices and legislation that affect the practice of the Nursing Service. Also, to ensure accurate record keeping, file management and profiling data.
• To maintain standards in ongoing health information, both electronic and paper based, ensuring safe keeping and confidentiality accurate record keeping of relevant data and profiling.
• To participate and contribute to the development of partnership working; to positively influence the development of services, through maintaining an awareness of multi-disciplinary agencies within the community. To ensure effective seamless patient care across partner organisations.
• To monitor and maintain health and security of self and patients in the working area. To identify and report changes that may increase risk to staff, patients and carers.
• To maintain job competencies through continuous professional development and attendance on relevant courses.
• To participate in Appraisal process in accordance with the Knowledge and Skills Framework.
• To undertake all mandatory / essential training as required by the Organisation.
• To adhere to Organisational Policies, procedures and protocols to promote the highest quality of care within the patient experience.
• To travel independently between sites.

Person Specification

Experience

Essential

• Evidence of previous administrative experience.
• Ability to demonstrate accuracy, efficiency, and attention to detail in written documentation.
• Previous experience of working within a team.
• Experience of working with patients requiring healthcare.

Desirable

• Demonstrate knowledge and understanding of the standards contained in the research governance framework for health and social care, and ICH-GCP (Good Clinical Practice).
• Experience of working in a research setting.
• Experience in the use of NHS Systems i.e Cito, EDGE etc.

Qualifications

Essential

• Educated to GCSE level in English, Maths and IT (pass at grade C or above) or equivalent experience.
• Willingness to undertake role specific competencies within 12 months.
• Certificate of Good Clinical Practice training or willingness to complete within 3 months.

Desirable

• Further education to A level in English, Maths and IT skills.

Knowledge & Skills

Essential

• Evidence of using ones own initiative.
• Knowledge of basic PC systems.
• Understanding of responsibility, accountability and confidentiality, relevant to the healthcare role.
• Ability to learn new skills and adapt existing knowledge.

Desirable

• Understanding of good Clinical Practice Guidelines.
• Venepuncture competency.

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.

Additional information
Employer details

Employer name

The Mid Yorkshire Teaching NHS Trust
Address

Pinderfields Hospital

Aberford Road

Wakefield

West Yorkshire

WF1 4DG

Employer's website