Technician - University of Southampton



Last updated:<02/11/2015>JOB DESCRIPTIONPost title:Clinical Trials Laboratory TechnicianAcademic Unit/Service:WISH Laboratory and Cellular Pathology R & D, Cancer Sciences UnitFaculty:Faculty of MedicineCareer Pathway:Technical and Experimental (TAE)Level:3*ERE category:n/aPosts responsible to:Research Fellow in WISH laboratory, Cancer Sciences Unit Posts responsible for:NonePost base:Laboratory basedJob purposeTo deliver clinical trial sample analysis and support novel assay development and validation for CDD sponsored studies in accordance to the agreement in place between CDD and SouthamptonThe post holder will be based initially in the WISH Laboratory and trained in immunological sample processing and assays, they will be willing to be cross-trained in IHC assays and work closely with the Research and Development team based in cellular pathology. The location and reporting will be determined by the CDD clinical trial requirements. An adaptable and enthusiastic approach to the day to day tasks is essential.To co-ordinate (under the direction of the line manager/s) the collection, logging, processing, and storage of patient samples for CDD sponsored clinical trials to agreed timelines, communication methods and contracts. To carry out clinical trial associated endpoints using a variety of immunological techniques such as flow cytometry, ELISA and and molecular pathology techniques (eg IHC) to the standards of Good Clinical Practice for Laboratories. To contribute to clinical trial reports and CDD update meetings. To be responsible for clinical trial equipment maintenance (in liaison with the Laboratory Operations Manager) and clinical trial laboratory stocks and consumables.Key accountabilities/primary responsibilities% TimeTo liaise with UHS research nurses to be responsible for the collection of human samples when required from the Southampton General Hospital site, and with CRUK clinical trial administrators, to coordinate the collection and processing/storage of samples from external centres.5 %To process and store samples using standard operating procedures within a GCP for laboratories compliant sample management system, requiring meticulous record keeping and database management for all processes undertaken. Techniques to include peripheral blood mononuclear cell (PBMC) isolation and cryopreservation, and storage of serum. Requesting and preparation of samples for IHC assays.15 %To carry out a range of tests using well defined protocols, analysing and evaluating the results, and contributing to the interpretation of results and the development of assays, including Flow Cytometry, ELISA, Luminex, ELISpot and cellular pathology techniques such as IHC.35 %Validation of biological assays, using flow cytometry, ELISA, Luminex, ELISpot techniques, and molecular pathology techniques specific to the trial. 5%High degree of meticulous record keeping of sample processing and analysis. Contribution to clinical trial report writing and CDD update teleconferences. Administrative tasks associated with CDD Biomarker funding, for example risk assessment of research activities, organisation of project meetings and documentation. .10 %To take a proactive role in the day-to-day organisation of the clinical trial laboratory, specifically clinical trial equipment maintenance and logs, and writing and updating Standard Operating Procedures associated with all work, processes and procedures relating to clinical trial activities.5%To advise on the pricing and purchasing of consumables and ensure adequate stocks of supplies.5 %To ensure accurate completion of all documentation, reports and records according to GCP for laboratories.5 %To ensure compliance with health and safety processes within work environment, including equipment maintenance in accordance with technical and health and safety procedures.5 %To train students or new staff members in techniques, procedures, and safe and effective use of equipment.5%Any other duties as allocated by the line manager following consultation with CDD and the post holder.5 %Internal and external relationshipsECMC Director and Biomarker Specialist Research Fellow within WISH facility as Line ManagersPrincipal Investigator for trial and external trial administrators/managers for contributions to reporting on trial progressCollaborative/administrative working with other WISH and cellular pathology staff, UHS research nurses, and QA managementCentre for Drug Development biomarker development specialist and members of CRUKReporting of CDD Biomarker contract metrics to appointed Service LeadSpecial RequirementsWilling to undergo vaccination against Hep B for occupational health.PERSON SPECIFICATIONCriteriaEssentialDesirableHow to be assessedQualifications: Knowledge: Experience:Skill level equivalent to achievement of HNC, A Level, NVQ3Understanding of validating biological assays.Working to SOPs under/ within a regulated laboratory environment.Experience of working within a quality management system.Relevant laboratory experience BSc Degree or equivalent qualification or experience.Relevant laboratory experience in a responsible role.Knowledge of and training in GLP / GCP/ISO accredited laboratory or similar. Experience of flow cytometry, ELISA or other immunological monitoring techniques. Experience of cellular pathology techniques and PBMC extraction from blood, Evidence / certificate CV ApplicationInterviewCV Application InterviewCV Application InterviewCV Application InterviewPlanning and Organising:Experience of co-ordinating the organisation and implementation of new process and procedures.Able to organise own research activities to deadlines and quality standardsInfluencing the organisation of a project on multiple sites.Reporting of project specific metrics CV Application InterviewProblem Solving and Initiative:Able to offer or accept appropriate level of assistance, to allow for effective progress.Willing to express constructive ideas.Propose initiatives and ideas with the ability to positively accept / acknowledge or implement new proposals.Ability to accurately analyse and interpret specialist data, presenting summary information in a clear and concise formatInterview & probationManagement and Teamwork: Able to work alone or within a small team complying within regulatory frameworks and contractual obligations. Experience of providing training to colleagues and students in relation to technical tasks.Understand the strengths and weaknesses of others to help teamwork development.Interview & ProbationCommunicating and Influencing:Effective communication across participating sites including ability to liaise with senior staff, including managers, nurses.Positive motivational influence on all parties concerned with this role, internal and external.Able to present research results at group meetings, and to trial management/principal investigators/external stakeholders to agreed timelinesInterview & ProbationOther Skills and Behaviours: Meticulous attention to detail for sample tracking via paperwork and databases.Positive attitude to work, and colleaguesComputer skills including data input / information retrieval via databases.Interview & ProbationSpecial Requirements:(Training given for all processes undertaken)Willing and able to work with biological human materials to include blood/blood products and tissue.Willing and able to work with liquid nitrogen for purposes of sample processing and storage.Willingness to attend any necessary training, courses or seminars related to the post.Ability to undertake out of hours workingInterview & ProbationJOB HAZARD ANALYSISIs this an office-based post?? YesIf this post is an office-based job with routine office hazards (eg: use of VDU), no further information needs to be supplied. Do not complete the section below.? NoIf this post is not office-based or has some hazards other than routine office (eg: more than use of VDU) please complete the analysis below.Hiring managers are asked to complete this section as accurately as possible to ensure the safety of the post-holder.## - 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.ENVIRONMENTAL EXPOSURESOccasionally (<30% of time)Frequently(30-60% of time)Constantly(> 60% of time)Outside work N/AExtremes of temperature (eg: fridge/ furnace)## Potential for exposure to body fluids## Noise (greater than 80 dba - 8 hrs twa)N/A## Exposure to hazardous substances (eg: solvents, liquids, dust, fumes, biohazards). Specify below:Frequent hand washingIonising 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 handlingRepetitive crouching/kneeling/stoopingN/ARepetitive pulling/pushingN/ARepetitive liftingN/AStanding for prolonged periodsRepetitive climbing (ie: steps, stools, ladders, stairs)N/AFine motor grips (eg: pipetting)Gross motor gripsRepetitive reaching below shoulder heightRepetitive reaching at shoulder heightRepetitive reaching above shoulder heightPSYCHOSOCIAL ISSUESFace to face contact with publicLone working## Shift work/night work/on call duties N/A ................
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