Technician .uk



Last updated:November 2015JOB DESCRIPTIONPost title:Clinical Trials Laboratory TechnicianAcademic Unit/Service:WISH Laboratory, 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:Office-based/Non Office-based (see job hazard analysis)Job purposeTo co-ordinate (under the direction of the line manager/s) the collection, logging, processing, and storage of patient samples for clinical trials and other research projects within the WISH laboratory, complying with all legal requirements within an ICH-GCP compliant regulated area. To carry out clinical trial associated endpoint and research assays. To contribute to clinical trial reports and sponsor update meetings. To be responsible for clinical trial equipment maintenance (in liaison with the Divisional Laboratory 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 an ICH-CGP 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.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 techniques, specifically analysis of whole blood by Flow Cytometry for a variety of panels and receptor occupancy assays. Also to carry out analysis of anti-drug-antibodies by ELISA.35 %Validation of biological assays, using flow cytometry and ELISA techniques, specific to the trial.5%High degree of meticulous record keeping of sample processing and analysis. Contribution to clinical trial report writing and sponsor update teleconferences. Administrative tasks associated with specified research 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 the post holder.5 %Internal and external relationshipsECMC Director and 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 staff, UHS research nurses, and QA managementSpecial RequirementsWilling to undergo vaccination against Hep B (with occupational health).PERSON SPECIFICATIONCriteriaEssentialDesirableHow to be assessedQualifications, Knowledge and Experience: Skill level equivalent to HNC, A Level, NVQ3 (or equivalent).Working to SOPs under/ within a regulated laboratory environment.Experience of working within a quality management system.Relevant laboratory experience.BSc Degree (or equivalent).Knowledge of and training in GLP / GCP or similar. Knowledge of Clinical Trial Directive.Experience of flow cytometry, ELISA and PBMC extraction from blood.Experience of validating biological assays.Evidence / certificate CV ApplicationInterviewPlanning 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 standards.Influencing the organisation of a project on multiple sites.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 format.Interview & probationManagement and Teamwork: Able to work alone or within a small team complying within regulatory frameworks. 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 and 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.Interview & ProbationOther Skills and Behaviours: Meticulous attention to detail for sample tracking via paperwork and databases.Positive attitude to work, and puter skills including data input / information retrieval via databases.Proficient user of Microsoft Packages (including Excel) 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 working.Interview & 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 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download