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Detailed job description and main responsibilities

Job description

KEY SKILLS

Study Set up:

·         To assist with the acquisition and distribution of relevant study documentation.

·         To assist in the preparation of research files and regulatory paperwork.

·         To establish” site files “for each study in accordance with ICH Good Clinical Practice (GCP) and Research Governance.

Ongoing studies

·         To collate and transcribe /export data from medical and other records (paper or electronic) to CRFs (paper or electronic) as required.

·         To check recruitment of patients into studies including checking consent paperwork and study specimen records and to ensure that all relevant data has been recorded.

·         To assist in ensuring compliance with study protocols and ethical approvals.

·         To assist in the preparation of internal and external annual study reports.

·         To develop IT tracking systems and ensure safe filing and storage of study documentation and samples in accordance with ICH GCP and research governance.

·         To liaise with study sponsors and research governance departments as required.

·         To take responsibility for checking and resolving data queries.

·         To attend meetings as appropriate and to take notes/minutes on request.

End of Study Responsibilities

·         To ensure study paperwork is filed correctly in accordance with the relevant CRF Standard Operating Procedure (SOP).

·         To facilitate the secure storage of study documentation in accordance with ICH GCP and Research Governance.

Finance

·         To be responsible for requesting all research related invoices according to the research study contract in the specified time frame.

·         To precisely complete the invoice request and submit to the finance department for processing.

·         Maintain accurate spreadsheet of requests submitted and of invoice numbers.

·         Resolve invoice queries

·         Ensure all financial transactions are completed in compliance with the Trust Standing Financial instructions

Communication

·         To communicate effectively with all disciplines of staff involved in the research study.

·         To liaise with outside research agencies such Clinical Trial Units, NIHR Clinical Research Facility, University Clinical Trials Unit and Research Ethics Committees regarding individual research studies.

·         To deal sensitively and in a professional manner on the telephone.

·         Responding appropriately to difficult and sensitive enquiries to ensure a satisfactory conclusion. Referring to the Research Team as appropriate for clinical responses.

·         Liaise with Trust staff, managers and outside agencies in a professional and courteous manner.

·         The post holder must be able to communicate information to a wide range of staff groups, i.e. Medical Consultants, Clinical Scientists, Researchers, Academics, Public and Patient groups and external stakeholders.

KEY RESPONSIBILITIES

General Administration

·         To carry out general clerical and office management duties and maintain an efficient filing system.

·         To ensure compliance with Trusts policies on data protection, confidentiality and security. To observe the confidentiality of participant information at all times, in accordance with the Data Protection Act 2018, GDPR and Trust policies.

·         To manage Research Databases, updating and developing them where necessary. The post holder will be expected to manage their own workload and to work independently. To collaborate with clinical and administrative staff to support the ongoing development of Database including advising of updates and errors as they arise.

·         To be responsible for the retrieval, collation, extraction and entry of accurate data and information, some of which may well be complex clinical information, from study patients into research databases.

·         To work in collaboration with Researchers and also assist in developing systems for efficient data collection and input, liaising with medical staff where necessary.

·         To be responsible for collecting and submitting clinical data to the clinical teams. The role of this post includes the examination of patient files and laboratory reports for collection and submission of data according to agreed study proforma.

·         To provide data from databases & spreadsheets and other information systems to authorised staff upon request.

·         To collaborate with the nursing and clinical teams to co-ordinate the submission and collation of data from other sites participating in Research Studies to ensure the accuracy and validity of data collection.

·         To undertake specific training and development required for effective performance of the post.

·         Prioritise all incoming work on a daily basis, including responding quickly and appropriately to urgent/important issues/queries referring to the Research/ Finance Team where appropriate.

·         Liaise with the consultant team, departmental staff within the speciality or support departments to ensure patients progress smoothly and appropriately within and between hospitals and, where necessary, back to GPs.

·         Drafting and typing of routine and ad-hoc correspondence and reports on behalf of the research team. Preparing presentation notes / slides as required. Taking minutes at specified meetings.

·         To undertake other administrative duties to include photocopying, printing etc.

·         Maintain accurate patient records to ensure that they are up to date and all correspondence/ results etc. are correctly filed to defined Clinical Governance standards.

·         Develop and maintain up-to-date filing.

·         Prepare, label and document samples for investigation adhering to all laboratory Standard Operating Procedures, maintaining sample logs for quality assurance and Good Clinical Practice/Good Laboratory Practice compliance.

·         Using initiative to identify all possible opportunities to anticipate, support and streamline the work and responsibilities of the nursing research team.

·         The post holder is required to work on their own initiative on a regular basis and manage their own workload; this will require excellent planning and organisational skills using their own judgment to prioritise their workload effectively.

MANAGEMENT , SUPERVISORY, TEACHING, TRAINING RESPONSIBILITIES

·         Act as a resource for colleagues in relation to clinical trials and invoicing queries

·         The post holder is to continue his/her own professional development keeping updated with current practice in research and finance.

RESEARCH AND DEVELOPMENT

·         The post holder will work within the Research & Development department, and will be directly involved with the administration of trials.

·         The post holder will be involved in internal audits and preparing for inspections.

EFFORT 

Physical Effort

·         Sitting at a desk using a computer for prolonged periods. Other activities include meetings and walking to other areas of the Trust. The post holder will also need to go into clinical areas to complete their clinical tasks.

Mental Effort

·         There is a frequent requirement for prolonged concentration e.g. writing reports, using electronic software packages e.g. Excel, Word, Project Manager.

Emotional Effort

·         Exposure to sensitive information in relation to research patients and confidential research projects.