Job Description
Trust: Royal Devon University Healthcare NHS Foundation Trust\nLocation: Exeter, Wonford, EX2 5DW\nJob Purpose:\nThe post holder will work as part of the clinical research team to support the safe conduct of research in accordance with the Research Governance Framework and Good Clinical Practice guidelines and provide assurance that the rights, safety and well-being of trial participants are protected.\nThe post-holder will work with the research team to provide administrative, clerical and data management support for all aspects of research study delivery across an extensive portfolio of clinical trials.\nKey Result Areas/ Principal Duties and Responsibilities:\nResearch and Governance\n• Assist the clinical research team in coordinating a portfolio of National Institute Health Research (NIHR) studies.\n• Participate in Good Clinical Practice (GCP) training and ensures GCP compliance of self and team.\n• Assist in study set up processes:\n• Expression of interest & study selection documents\n• Liaise with the study sponsor, R&D facilitator team, relevant support and research teams to assist in the successful set up of new studies\n• Prepare submissions for local research and development approval\n• Coordinate site initiation meetings\n• Set up the local site file & collate documents\n• Ensure EDGE is correctly set up & data correctly maintained throughout the study\nTake a leading role in on-going study coordination including:\n• Conduct regular site file maintenance to ensure study essential documents are version controlled and maintained according to regulatory requirements\n• Maintain effective communication between the study sponsor and the clinical research team\n• Support local implementation of study amendments\n• Update quality systems to record study information and enrolled patients details\n• Coordinate and prepare documents for patient visits\n• Respond to patients/carers telephone calls tactfully and professionally\n• Book trial specific investigations and procedures\n• Coordinate study monitoring visits\n• Assist with data queries and AE / SAE reporting\nTake a leading role in study close out procedures including:\n• Liaise with the sponsor for final monitoring visit\n• Preparing study documents for archiving\n• Liaise with R&D and following archiving SOP & procedures\n• Assist with data entry according to study complexity and ensure that data is transcribed accurately where required.\n• Support internal audit and monitoring.\nService Delivery and Improvement:\n• Take a leading role in providing all aspects of general administration and clerical work for the\nclinical research team including but not exclusively:\n• Document preparation\n• Book couriers & coordinate sample collections\n• Taking phone calls\n• Book Appointments\n• Email and fax correspondence\n• Typing letters\n• Maintaining databases, shared drives, generic email boxes and calendars\n• Filing\n• Patient records requests and collection\n• Gaining signatures\n• Office management (including electronic calendar / diary management\nThe post holder is required to deal effectively with staff of all levels throughout the Trust as and when\nthey encounter on a day to day basis\nSystem Knowledge:\nUse of Word/Excel to populate documents, send letters. Answer phone calls, collect signed documents, desire to complete training such as GCP (M) Inputting into databases/EPIC (D)\nKnowledge/Skills:\nExcellent Organisational Skills\nPlanning/Organisational Skills\nAnalytical / Jugemental Skills\nCommunication/ Relationship Skills\nResearch and Development\nWorking knowledge of Microsoft office packages (spreadsheets, databases,\nword processing and e-mail)\nAbility to communicate with staff and patients\nAbility to prioritise workload to respond to changing demands\nExcellent telephone manner and written communication\nUnderstanding of National Institute for Health Research Clinical Research Network\nUnderstanding of the clinical research process including Good Clinical Practice\nPhysical Skills:\nThe post holder will be required to use their IT skills including MS Office, Google docs, internet, databases etc. in order to monitor activity, systems and processes and to produce reports\nincluding in time-bound circumstances.\n• Standard/good keyboard skills are required for the inputting and manipulating of data and/or information on computer databases.\nExperience :\nSubstantial administrative or clerical experience\nPrevious employment within a healthcare setting\nClinical Research experience\nData management experience\nPersonal Attributes :\nEnthusiastic, motivated and committed to developing a professional service\nFlexible approach to work and the needs of the service\nAble to prioritise and use own initiative\nRemain calm in difficult situations\nProven ability to work as part of a multi-disciplinary team\nExcellent communication skills; confidentiality, tact and diplomacy\nOther Requirements :\nAbility and willingness to work across multiple sites\nThe post holder must demonstrate a positive commitment to uphold diversity and equality policies approved by the Trust.\nCommitted to further professional development\n** Applicants are given a short word and excel test within time slot during interview