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Clinical Trials Co-ordinator (XN05)
| Posting date: | 12 July 2024 |
|---|---|
| Salary: | £28,407.00 to £34,581.00 per year |
| Additional salary information: | £28407.00 - £34581.00 a year |
| Hours: | Full time |
| Closing date: | 01 August 2024 |
| Location: | Leeds, LS9 7TF |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9298-DRI-0156 |
Summary
KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED The post-holder will be educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post. They would be expected to have experience of working in an organisation which includes interaction with multiple departments or organisations. The post holder will be expected to show a thorough understanding of all legal requirements related to trials and must be familiar with GCP/ICH guidelines and the Declaration of Helsinki. The post requires evidence of relevant experience of Clinical Trials co-ordination and data management skills. Excellent communication skills and the ability to provide and receive complex information in relation to study design are essential for this role. Excellent organisational, negotiation and presentation skills are essential, as well as the ability to work on their own initiative and as a team player. CORE BEHAVIOURS AND SKILLS Professional attitude to work, diplomatic and calm under pressure Ability to work as a team in a busy working environment Excellent communication skills, able to communicate at all levels Strong interpersonal skills Effective organisational skills Ability to prioritise and manage time effectively Ability to work autonomously and own initiative Proactive and flexible approach Motivated, friendly personality Commitment to personal development Coach and develop staff Ability to motivate staff. CORE KNOWLEDGE AND UNDERSTANDING The post-holder will be expected to demonstrate complete understanding of Clinical Trial legal requirements and management. The post-holder will be expected to have knowledge of the complete trials process Experience of staff supervision would be desirable. Whilst a knowledge of Clinical Trials is essential, knowledge of the NHS and clinical area is desirable and would be an advantage PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY Clinical Trial Portfolio Management To be responsible for coordination of clinical trials ensuring that trial protocols are adhered to. This will include management of the trial portfolios consisting of commercial and national studies from trial agreement through to completion of the study. Be accountable for the preparation of clinical trials for conduct in the department, and Innovation (R&I) and support service departments in line with local Trust trial including review of trial protocols, submissions to ethics committees, Research procedures, trial indemnity arrangements and all regulatory requirements To take the lead in all other trial administration procedures i.e. ethics and R&I reports Ensure that all contracts, indemnity agreements and all other trial related documents are in place prior to commencement of studies. Ensure regulatory and governance issues are adhered to Ensure recruitment information is up to date and comprehensive on all relevant clinical trial databases e.g. EDGE Register and randomise patients into trials. Extracting clinical data from medical records onto Case Report Forms (CRFs) in liaison with clinicians, research nurses and medical records staff. Ensure all protocol amendments/addendums are processed and implemented accurately To be the main contact point for all trial related activity within the portfolio and delegate work as appropriate. To work with the relevant research groups to develop specific clinical trials portfolios Liaise closely with research nurses regarding day to day trials management. To regularly review clinical trial activity and assist in analysis of complex clinical trial information Preparing work sheets that highlight the necessary data to be captured for particular trial patient visits, for use as primary source documents when required. Ensure that any queries on the CRFs are logged and dealt with quickly by the relevant clinician/research nurse. Ensure that the data recorded on the CRFs of trial participants are entered onto the computer database completely and accurately in a timely fashion. Identify any problems with entry of data onto database and work with the relevant staff to resolve them. To collate and report the data from all centres participating in the trial on a continuous basis to ensuring that expected and un-expected adverse events are identified early and the appropriate decisions are taken regarding trial recruitment. Responsibility for timely reporting of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSARS) to the appropriate trial sponsors or regulatory authorities, in liaison with the Research Nurses/Midwives/AHPs and Principal Investigator. Plan the administrative management of the specific research projects including the establishment and maintenance of office systems. Compile and maintain a master set of source documents and trial master/site file for each specific project. Responsible for the maintenance of all clinical trials office systems including log books, databases, protocols, and patient information sheets and protocol site files. Coordinate and prepare necessary papers/documents for key meetings and take minutes at the meeting as required. Assist in the functioning of the electronic quality management systems utilised within the department, including document uploads and tracking. Assist in the statistical analysis of clinical trial results as appropriate. Attend trial close down meetings following trial completion and supervise the preparation of documents archiving of study site files All trial functions to be undertaken in accordance with GCP, advise on GCP queries from other centres. Attend regular administration and general team meetings. Attend all trial related meetings. This may involve national or international travel. General administrative duties arising from the clinical trials activity of the unit, as appropriate to this post. Development of Clinical Research Attend academic meetings re protocol developments To advise clinicians on the process of obtaining approval for local trials and to support the submission of applications. To produce clear and well-designed data collection forms, and specify particular requirements for the project database. Work with the relevant staff on the design, validation, production and management of databases and information systems used for the collection, analysis, and presentation of trials data. Facilitate the development of audit projects and present findings at designated meetings as appropriate. Financial Management and Negotiation To negotiate with local Trust service support departments regarding costing of clinical trials, e.g. pharmacy, radiology, and pathology, and negotiate set up contracts Undertake cost comparisons to assess departmental costs. Check eligibility and organise regular payments of travel expenses to patients on clinical trials. Checking eligibility of payments to patients. To liaise closely with the Finance Managers regarding the financial management for each clinical trial, calculating all payments involved, ensuring invoices are raised and keeping a log of all payments made. Communication Establish and maintain effective working relationships with all relevant organisations and individuals; LTHT R&I, other NIHR research teams, other providers of NHS services, Clinical Trials Units, and Industry. Liaise with research staff in other units participating in the clinical trial to ensure accurate recording and timely submission of data to the centre, as per protocol, electronically or by other means in real time. To provide feedback to the relevant research groups on trial recruitment and status and to highlight areas of excellence and concern. To provide information about existing and new trials to clinicians, research nurses and data managers. Liaison with research staff to monitor trial recruitment. Work with the Principal Investigator for each trial to ensure he/she is constantly up to date for the trial. Deliver presentations at meetings as appropriate. Answering telephone queries from trials centres, patients, clinicians and health professionals regarding specific trials. Staff Management Supervise the day to day workload of clinical trials assistants including their trials related data collection and general study administration. Participate in own and others appraisals The Leeds Improvement Method: has a responsibility to improve the quality and safety of our service. It is expected that in fulfilling a leadership role you will be proactive in promoting and using the Leeds Improvement Method Quality Assurance Involvement in the writing and updating of Standard Operating Procedures (SOPs) amending in line with changing legislation and circumstances. Undertake regular monitoring visits to ensure that research complies with research governance guidelines. Actively promote and use the Leeds Improvement Method to improve the quality and safety of the service. Professional Development Complete Mandatory and Priority training within the specified timescales To maintain a high level of knowledge concerning clinical cancer research in all the areas covered by the network. To develop and maintain appropriate information technology skills if necessary by attendance at formal training courses. Health and Safety/Risk Management All staff are responsible for working with their colleagues to maintain and improve the quality of services provided to our patients and other service users. This includes complying at all times with the Leeds Teaching Hospitals NHS Trust Policies, including Health and Safety policies, in particular by following agreed safe working procedures, and reporting incidents using the Trust Incident Reporting system.