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Salary: £25,742 to £26,444, with progression to £27,979 per annum
Newcastle University is a great place to work, with excellent benefits .
We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.
Closing Date: 04 December 2023
You will assist with the management of observational nationwide clinical studies, supporting the Newcastle NIHR BRC Liver Theme.
Analysing large patient cohorts, liver theme investigators are conducting research focused on (1) the progression of liver disease to cirrhosis and primary liver cancer, called hepatocellular carcinoma, (2) the identification of biomarkers predicting response to therapy and (3) novel therapeutic target discovery.
You will assist with the management of projects professionally and in accordance with relevant regulations from first customer contact through to archival of project documentation; providing evidence demonstrating that the research conducted in NUTCRI and Newcastle-upon-Tyne NHS Hospitals Foundation Trust safeguards the wellbeing of patients and produces credible data.
This is a full time post, fixed term for 3 years
For informal enquiries, please contact Helen.
• Transcription of data from patient records to Case Report Forms as required by a specific clinical trial.
Patient records may include electronic patient notes, laboratory test results, image reports or data acquired from questionnaires patient diaries etc.
Case Report Forms may be based on an electronic or paper system• Liaising with a range of internal and external interested parties such as senior clinical and non-clinical staff, funders, PI’s and nursing staff, reviewing patient records to proactively and independently retrieve required data.
Will need to access external patient records and Hospital information systems where necessary• Ensure that all data reporting requirements both internally and externally are met, including responding to routine deadlines and ad hoc information requests• To take responsibility for all data security and integrity in line with University and Trust policies• Ensure that University and Trust policies in relation to Data Protection/Caldicott Guidelines are adhered to, including checking that all data capture systems used comply with this• Collation of information and paperwork for reporting of Serious Adverse Events (SAE’s) that may occur during the course of the clinical trial at the local (Newcastle) site.
This includes ensuring the relevant information is available for the completion of forms, obtaining relevant signatures and sign-off from a clinical member of the team and ensuring the reporting process is followed as required for the specific clinical trial (e.
faxing to a central point)• May be delegated by clinical team members to register and randomise patients into clinical trials• Ensuring patient investigation results are received, seen by the relevant member of the study team (usually a clinical or nursing member of the clinical trial team) and ensuring they are recorded and filed appropriately• Be responsible for anticipating requirements for and ordering supplies of data capture documentation.
Liaise with the nursing and clinical team to maintain sufficient stocks of clinical equipment required for individual trials• To act as a point of contact for regional, national and international data queries• To liaise regularly with counterparts nationally to ensure that there is consistency of approach in data collection to facilitate audits across the centres in the UK• Organise meetings for visit of monitors and/or auditors.
This will include arranging meeting rooms, ensuring relevant patient notes are available, ensuring the site study file is accurate and up to date.
Act as the point of contact for their visit to the site• To routinely audit data quality on the manual and electronic systems within the department to ensure that high standards are met and comply with University and Trust external governing bodies’ requirements• Assist the Clinical Trials Co-ordinators in all aspects of maintaining records of patients on trials and the regulatory issues that govern the management of clinical trials• Help with the preparation for, and facilitation of, audits and/or inspections• Ensure archival of closed study documentation is completed in accordance with local policy• Provide administrative support when needed as directed by their line manager• Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy• Take responsibility for identifying own learning needs, including identifying appropriate courses to ensure up to date knowledge in the regulations governing clinical research and research data• Be aware of and take responsibility for working in accordance with applicable regulations and guidance including the International Conference on Harmonisation (ICH) Guidelines on Good Clinical Practice, UK Regulations on Clinical Trials, Data Protection Act and Research Governance Framework for Health and Social Care• To assist with other research administrative functions within the department to provide cover for staff absence due to holidays and sickness• There is not normally any responsibility for managing other staff but there may be a need to supervise any temporary support required to assist with special projects or events • Required to make decisions, using trial specific tools, when transcribing data into Case Report Forms.
This will be in relation to clinical information and will involve relating the request for information to what is actually recorded in the notes
Knowledge, Skills and Experience (Essential) • Knowledge of medical terminology• Knowledge of University and Trust policies regarding Data Protection Act and the Caldicott Guidelines• Experienced in all aspects of Microsoft Windows applications• Able to concentrate on routine tasks whilst maintaining attention to detail• Excellent interpersonal and communication skills (both written and verbal)• Good time management skills• Ability to prioritise workloads• Ability to accurately transfer data from one medium to another using both paper based and electronic data capture• Previous Database and Data Management experience• Evidence of Admin and Clerical experience• Experience within NHS/clinical research
Desirable • Knowledge of liver disease and liver cancer terminology and staging• An understanding of Good Clinical Practice (GCP) and other regulatory processes involved in clinical trials• Demonstration of a knowledge of Serious Adverse Event (SAE) procedures• Knowledge of E-Record
Attributes and Behaviour (Essential) • Meticulous about following processes and procedures and able to organise workload and paperwork accordingly• Self motivated and able to work with minimum supervision• Willing to undertake personal development training as required• Flexibility to work unsocial hours when urgent data capture/resolution is necessary• Able to work flexibly across both NUTCRI and Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Desirable • An interest in clinical research• An interest in liver disease and liver cancer
Qualifications (Essential) • Educated to A level standard or equivalent
Desirable • European Computer Driving licence qualification or equivalent
Newcastle University is a global University where everyone is treated with dignity and respect.
As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.
We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society.
We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent.
We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.
At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality.
We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education REC.
We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.
In addition, we are a member of the Euraxess initiative supporting researchers in Europe.
Requisition ID: 26418