Salary: £25,742 to £26,444 with progression to £27,979 per annumNewcastle University is a great place to work, with excellent . 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: 23 June 2024The RoleThis is an exciting opportunity for a talented and motivated individual with good organizational and communication skills to join an international, multidisciplinary team working in the area of translational research for neuromuscular diseases.Based at the John Walton Muscular Dystrophy Research Centre (JWMDRC) at Newcastle University, you will play a key role supporting the Registry project managers with curation, administration, and promotional activities in support of the various UK and International neuromuscular patient registries.This is an interesting role and you will have excellent knowledge of good data management principles, evidence of ability to identify errors in data, data query management and data reporting.This full-time post is tenable until 31/07/2025 with the potential to be extended further.The post will be based at the John Walton Muscular Dystrophy Research Centre (JWMDRC) at Newcastle University.Please note that if you are successful to this role, you will require medical clearance before you can commence in the role.Informal enquires to Julie Bohilla,For further information please see:Key Accountabilities
- Communicate with clinic sites on behalf of the Patient Registries with regards to patient registration and completion of clinician-reported data in the online Patient Registries
- Communicate with Patient Registry participants to support completion of registry questionnaires, including PROMs
- Work with Neuromuscular Patient Registries and related projects to provide data of all consented Patient Registry participants, to be aligned, fully anonymised and submitted for review by regulatory authorities
- Work with Neuromuscular Patient Registry Project Managers to provide twice yearly reports of registry activities
- Transcription of data from patient records to registry Case Report Forms as required by specific clinicians. Patient records may include medical notes (often handwritten), laboratory test results etc. Case Report Forms may be based on an electronic or paper system
- 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
- 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
- Support work to ensure that all data reporting requirements both internally and externally are met, including responding to routine deadlines and ad hoc information requests
- Adhere to University and Trust policies in relation to data security and integrity
- Adhere to University and Trust policies in relation to Data Protection/Caldicott Guidelines
- Routinely audit data quality on the manual and electronic systems within the Neuromuscular Patient Registries database to ensure that high standards are met and comply with University and Trust external governing bodies’ requirements
- Help with the preparation for, and facilitation of, audits and/or inspections
- 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 JWMDRC as required and to provide cover for staff absence due to holidays and sickness
- 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
- An understanding of Good Clinical Practice (GCP) and other regulatory processes involved in clinical trials
- Knowledge of E-Record
- Experience within NHS/clinical research
- 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
- An interest in clinical research
- Educated to A level standard or equivalent
- European Computer Driving licence qualification or equivalent