Template Job Description - Southampton



JOB DESCRIPTIONPost title:Clinical Trial CoordinatorSchool/Department:Clinical and Experimental Sciences - Vision SciencesFaculty/Directorate:MedicineJob Family:Management, Specialist and Administrative (MSA)Level:4Career Pathway (*ERE):N/APost title of Line Manager:Associate Professor of OphthalmologyPost title(s) responsible for:NonePost base:Office-based at Southampton General HospitalJob purposeTo take responsibility for the development and operational management of the Medical Research Council funded OLIVIA Study (including financial aspects): Feasibility of a phase 3 randomised controlled trial of Oral Levodopa treatment in Improving Visual development in Infants and young children with Albinism.Key accountabilities/primary responsibilities% TimeTo provide key administrative support to the Chief Investigator, in particular: Assisting with trial development in collaboration with Chief Investigators and other relevant personnel.Ensuring regulatory requirements are fulfilled and that all approvals and authorisations are secured. Taking responsibility for applicationsas appropriateAs appropriate assist with the development and maintenance of SOPsTaking responsibility for trial set up and activation, establishing links with key members of staff and ensuring essential documentation is in placeMonitoring trial conduct as appropriate to ensure protocol compliance and good patient managementEnsuring the appropriate randomisation service is available and assisting with this service as necessaryIdentifying when protocol amendments become necessary and taking appropriate actionEnsuring the trial recruits at an acceptable rateActing as the main point of contact for the trialOrganising and participating in relevant trial specific meetingsTo perform regular stock takes to ensure secure and adequate stocks are held of marketing and publicity materials, stationery, equipment and consumables To ensure continual development of systems, processes and quality service standards, including the office procedural manual 40 %The maintenance, updating and development of electronic and manual filing systems. In particular: To record, scan and perform efficient filing of all incoming study data Writing and submitting trial progress reports as and when required Participation in the development and maintenance of quality systems and clinical audit of research activity, making recommendations for improvements where identified and implementing agreed change.20 %To communicate with study patients in a sensitive and efficient manner. In particular:To keep patient identifiable data up to date Explaining and promoting the trial (including newsletter production, website updates) to ensure wide participation and good accrual of patients.To conduct phone screens to assess patients for eligibility10 %To undertake Agresso financial administration processes and to provide support to management with budget monitoring processes. In particular: To process all invoices/credit card payments To raise invoice/payment requests (e.g. commissioned fees, travel expenses, conference bookings) and submit them for payment to the central finance office, to ensure accuracy/correct payment in a timely manner To keep finance spread sheets up to date and to produce figures and financial reports and required5%To organise meetings for the OLIVIA study and for the Chief Investigator, in particular: To book venues, residential accommodation and catering arrangements To provide assistance with travel arrangements for attendeesTo provide assistance with the production of event literature5 %External communication: to provide straightforward advice and support to, or seek information from, clinical staff, allied health professionals and participants in the study. In particular: To act as an initial and effective filter for issues and/or problems addressed to the Chief Investigator, aiming to resolve them where appropriate in order to provide effective support and problem resolutionTo provide detailed advice and guidance on specialist defined processes and procedures, using judgement to suggest the most appropriate course of action where appropriate10 %Any other duties as allocated by the line manager following consultation with the post holder.10 %Internal and external relationshipsTrial Chief Investigator and other members of Trial Management GroupCollaborating organisations Research nursesPharmacistsNHS staffStudy participants/patientsTrial funder (Medical Research Council)Trial oversight committees (DMEC, TSC)Other members of the School/Service Regulatory agencies e.g. HRA, Research Ethics CommitteesVerbal, written and electronic communications to?study participants,?NHS staff and research support?staff, collaborators based at other Universities,?appropriate staff within the School and across the University, including links to the Finance Officers based at Southampton?to ensure the provision of a professional support service.?Special Requirements of the RoleTo maintain confidentiality.??PERSON SPECIFICATIONCriteriaEssentialDesirableQualifications, knowledge and experienceDegree (or equivalent) in a biomedical or associated subject.Knowledge and experience of medical research methodology and statutory clinical trial regulations, GCP and research governance requirements.Relevant work experience preferably in a University research environment. High level of expertise with relevant IT packages including word, excel and outlook. Experience of financial record keeping and maintenance of budgets. Experience of working with University Finance systems (e.g. Agresso) or similar finance systems. Ability to write clear and accurate reports for internal and external audiences.Postgraduate qualification in relevant area. Health care background / Nursing qualification. Previous work experience with Clinical Trials AND/OR in the NHS.GCP training within last 2 years.Demonstrate commitment to maintaining professional knowledge and awareness through continuing personal and professional development.Expected Behaviours Able to apply and actively promote equality, diversity and inclusion principles to the responsibilities of the role. ANDDemonstrate the Southampton Behaviours and work with colleagues to embed them as a way of working within the team.Management and teamworkAble to proactively work with colleagues in other work areas to achieve outcomes.Able to delegate effectively, understanding the strengths and weaknesses of team members to build effective teamwork. Planning and organisingExperience of effectively planning and prioritising one’s own and the team’s varied workload in order to produce work of a high standard to required deadlines.Problem solving and initiativeAble to develop understanding of long-standing and complex problems and to apply professional knowledge and experience to solve them. Communicating and influencingAble to provide accurate and timely specialist guidance on complex issues. Able to use influencing and negotiating skills to develop understanding and gain co-operation.?? Ability to liaise with individuals at all levels at different establishments. Communicates effectively in both spoken and written English.Special requirements (of the postholder)To maintain confidentiality.JOB HAZARD ANALYSISIs this an office-based post, with routine hazards?? YesThis is an office-based post with routine office hazards (eg: use of VDU), no further information needs to be supplied. Do not complete/remove the section below.? PartlyThis is an office-based post with some non-routine hazards (eg: contact with the public and/or shift work). Please complete the analysis below.? NoThis is a non office-based post and has some hazards. Please complete the analysis below. HIRING MANAGERPlease complete this section as accurately as possible to ensure the safety of the post-holder.ENVIRONMENTAL EXPOSURESOccasionally (<30% of time)Frequently(30-60% of time)Constantly(> 60% of time)Outside work N/AExtremes of temperature (eg: fridge/ furnace)N/A## Potential for exposure to body fluidsN/A## Noise (greater than 80 dba - 8 hrs twa)N/A## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes, biohazards). Specify below:N/AFrequent hand washingN/AIonising radiation N/AEQUIPMENT/TOOLS/MACHINES USED## Food handling N/A## Driving university vehicles(eg: car/van/LGV/PCV) N/A## Use of latex gloves (prohibited unless specific clinical necessity)N/A## Vibrating tools (eg: strimmers, hammer drill, lawnmowers) N/APHYSICAL ABILITIESLoad manual handlingN/ARepetitive crouching/kneeling/stoopingN/ARepetitive pulling/pushingN/ARepetitive liftingN/AStanding for prolonged periodsN/ARepetitive climbing (ie: steps, stools, ladders, stairs)N/AFine motor grips (eg: pipetting)N/AGross motor gripsN/ARepetitive reaching below shoulder heightN/ARepetitive reaching at shoulder heightN/ARepetitive reaching above shoulder heightN/APSYCHOSOCIAL ISSUESFace to face contact with publicXLone workingN/A## Shift work/night work/on call duties N/A## - HR will send a full PEHQ to all applicants for this position. Please note, if full health clearance is required for a role, this will apply to all individuals, including existing members of staff. ................
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