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Research Assistant
1 month ago
Job summary
Join a small friendly department committed to developing and retaining its members of staff to cultivate a high performing, cohesive team, who enjoy coming to work and feel valued.
An opportunity has arisen to join us in a dual role as an oncology Clinical Trials and a Research and Development Assistant focussing on invoice requests. We are seeking an enthusiastic and hardworking person experienced in clinical research trial administration and invoicing. You will be responsible for providing data management and research administrative support for clinical study activities. You will be supported by the research teams.
The successful candidate should be well organised, able to manage time effectively and work independently on administration of the research trials being run in the department. The post holder is expected to contribute to databases for clinical studies and registries of research patients for local and national research projects. This will require the post holder to combine their IT knowledge with knowledge of the clinical research process.
The post holder will require excellent communication skills and be able to demonstrate an ability to work under pressure and to tight deadlines.
You will also be responsible for the passing of all research related invoices for payment, ensuring adherence to the Trust Standing Financial Instructions. The role also requires liaison with trial offices and Clinical Research Organisations (CROs) to resolve invoicing queries
Main duties of the job
This varied dual role requires very good attention to detail with excellent coordination skills. You must be efficient and organised, being able to plan your workload for each half of the role and work on them separately devoting the same level of commitment and dedication to each.
In the oncology research assistant role you will work with the research team and research and development from set up to closure of both commercial and academic clinical trials. This must all be in accordance with Good Clinical Practice (GCP).
The research and development half of the role is vital to the department with the main focus being to ensure that all income that is due is claimed accurately and within the prescribed time frame.
About us
Bedfordshire Hospitals NHS Foundation Trust provides hospital services to a growing population of around 700,000 people living across Bedfordshire and the surrounding areas across two busy hospital sites in Bedford and Luton. Both hospital sites offer key services such as A&E, Obstetrics-led Maternity and Paediatrics. You will be joining a friendly, high performing Trust committed to ensuring the health and wellbeing of staff. As one of the largest NHS Trusts in our region you will have access to a programme of high quality training and development to help you grow your career. The Trust continues to be committed to delivering the best patient care using the best clinical knowledge and technology.
Our Values
We not only recruit based on qualifications and experience - we recruit individuals who demonstrate the behaviours which underpin our Trusts core values. We achieve this by using values based recruitment. We are dedicated to making our recruitment practices as inclusive as possible for everyone, we are committed to promoting equality and diversity, and creating a culture that values differences.
Please note that vacancies may close prior to the advertised closing date when sufficient number of applications have been received. All new staff will be subject to a probationary period covering first 6 months in post. Travel between hospital sites may be required. Please review all documents attached to ensure you familiarize yourself with all requirements of the job.
Job description
Job 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, 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 writing reports, using electronic software packages Excel, Word, Project Manager.
Emotional Effort
Exposure to sensitive information in relation to research patients and confidential research projects.
Person Specification
Qualifications
Essential
Maths & English at GSCE level, Grade C or above NVQ Level 3 or equivalent comparable experience
Desirable
Education to A level or equivalent AAT level 1 GCP certificate
Experience
Essential
Previous office experience Evidence of administrative or clinical audit experience in an NHS setting
Desirable
Previous experience working in a finance department
Skills
Essential
Evidence of well-developed IT Skills including Microsoft Word, Excel, Outlook etc. Experienced user of reporting tools and ability to update skills as necessary. Ability to work under own initiative and to prioritise and manage own workload. Accurate and attentive to detail Excellent numerical and written skills. Able to work independently and as part of a team. Well-developed communication skills. Ability to seek out information when not readily available.
Desirable
Knowledge and use of local clinical computer applications ICE iPM and EVOLVE. Able to produce reports and graphs
Other
Essential
Ability to establish and maintain good working relationships with all people relevant to their work. Ability to be proactive in problem solving and take initiative with an awareness of own limitations. Have the emotional resilience to support patients and carers. Motivated, able and willing to learn. Good time keeping Evidence of being a team player
Desirable
Knowledge of medical terminology Working knowledge of patient confidentiality/ Caldicott guidelines Awareness of Research Governance as far as it affects collection of research Study data Adaptable