Senior Clinical Trials Assistant

Job summary

The Haematology Clinical Trials Department offers a busy and dynamic environment, supporting the delivery of a large portfolio of Phase I - III Clinical Trials.

We are looking for a passionate and motivated individual to join us in the exciting role of Senior Clinical Trials Assistant at St Jamess Hospital, Leeds. We can truly make a difference to an individuals care and experience within LTHT and we strive to ensure research is considered as a treatment option for all eligible patients.

The candidate must have clinical trials experience and be able to demonstrate experience/ understanding of how clinical trials are run in the NHS. They will have worked on various EDC systems and be able to work autonomously to answer all data queries on a number of trials within the portfolio.

Main duties of the job

The successful candidate will help support the delivery of a high-quality service and ensure the team work collaboratively and maintain the large portfolio of complex studies running within the department. They will work closely with the Admin Team, Research Nurses, Investigators and Sponsors.

The Senior Clinical Trials Assistant role involves coordinating the Haematology portfolio, submitting study feasibilities, new trial set up and running the weekly disease group meetings. They will track all patient activity, SAEs, deviations and ensure the tracking logs are maintained.

They will be the initial point of contact for all recruiting trials within their disease group and track patients throughout their journey in a Clinical Trial, collecting complex data to enter into case report forms, attention to detail is essential. They will ensure all trial protocols are adhered to and work with study monitors to facilitate monitoring visits, answering data queries, and adhering to Good Clinical Practice.

They will maintain the study site files, filing essential documents and processing amendments involving multiple departments within the Trust.

About us

Research is at the heart of our Trust. Leeds Teaching Hospitals 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, teams involved in clinical research delivery in Health and Social Care.

Our five Trust values are part of what make us different. They have been developed by our staff. They are:

- Patient-centred

- Collaborative

- Fair

- Accountable

- Empowered

Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.

Job description

Job responsibilities

JOB PURPOSE

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

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/Clinical Trials Manager 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, raising of invoices and support the research nurses where fit.

JOB DIMENSIONS

The post holder will be working within the rapidly expanding Haematology 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.

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 co-ordination of tests, obtaining results and arranging transport and documentation of specific specimens as per clinical trial protocols

Assist the Senior Research Nurse / Research Nurses in the development of systems and procedures for safe trials operations adverse event reporting, updating protocols, communication of revisions etc. to ensure safe operation of the trials in line with ICH-GCP standards

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 trials 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 (training will be given).

The post holder may be required to undertake some clinical skills clinical observations, venepuncture or taking of electrocardiographs (ECG). This will be as directed by the Senior Research Nurse and training will be given.

To assist the co-ordination of the patients journey through the clinical trial protocol , requisition and organisation 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 to the MDT.

Attend meetings as required by the Senior Research Nurse 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.

Arrange departmental meetings, including booking venues, sending out papers and taking minutes

Assist the Senior Research Nurse 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 with the preparation of documentation for submission to regulatory authorities and follow up on 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 data bases, ensuring information is accurate and up to date

To report monthly to the Senior Research Nurse accrual data on all patients recruited into the study portfolio highlighting local activities that might impact on achievement of the departments research aims.

Liaise with external companies, sponsors, and regulatory authorities to address any queries resulting from trials in progress

Assist the Senior Research Nurse/ 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 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

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 always maintain patient confidentiality.

The post holder will always act in a professional manner 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 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 always work to ICH GCP guidelines.

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 Trusts 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.

Person Specification

Other Criteria

Essential

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

Qualifications

Essential

Good standard of education NVQ level 3 or equivalent

Experience

Essential

Clinical trials experience Previous administrative experience Experience working in NHS having contact with patients in either a clinical or research setting

Desirable

Previous experience of working within Clinical Trials Management within the NHS Informed consent experience Knowledge of research methodologies Understanding of the NHS and the organisation

Skills & Behaviours

Essential

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

Desirable

Previous clinical skills training taking clinical observations, venepuncture, ECG

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