Detailed job description and main responsibilities

Communication and working relationships

·         Biochemistry laboratory duties: Accountable to Biomedical Scientists, Head BMS and Head of Department.

·         Research duties: Accountable directly to the Head of Department and Head BMS.

·         Liaise with Research and Development, Clinical Trial Nurses, and sponsor Clinical Research Associates using specialist knowledge to resolve general and technical queries that may require investigation of current or historic trials that requires a high level of experience in research.

·         Represent the laboratory in study Site Initiation Visits (SIVs) with Research and Development, senior Clinical Trial Nurses (CTNs), Principal Investigator (PI) and sponsor Clinical Research Associates (CRAs); extracting relevant information and answering technical questions using specialist laboratory and research knowledge.

·         To liaise with courier companies by telephone, email, or web request to arrange pick-ups and deliveries to reference laboratories, specific to each study.

·         Maintain good communication with other Research Medical Laboratory Assistants (MLAs) to ensure team members have consistent contemporary knowledge of current research tasks, calling team meetings when necessary.

·         Contribute to a small team of Research MLAs supporting R&D and simultaneously contribute to the general biochemistry MLA team and Biomedical Scientists in provision of an analytical service to Primary and Secondary Care.

·         Provide in-person lab inductions to new research nurses/R&D staff, to form good working relationships, and provide specialist instruction for interdepartmental collaboration, to allow labs to provide high quality service for R&D.

·         Provide in-person lab tours to external sponsor clinical research associates when performing on site inspections – Prepare and produce required documents for the CRAs and answer any specialist questions during their visit.

·         Deal with telephone enquiries from medical, nursing, and other healthcare professionals. Calls include requests for test results, queries regarding blood sample tube types, requests for emergency tests, and add ons. Any more complex queries are referred to senior members of staff.

         ·   Regularly check the computer-generated outstanding work lists for missing results from reference laboratories and follow up with telephone calls to the relevant laboratory where necessary.

Planning and organisation

·         Must draw on specialist knowledge gained from GCP certification and research experience to review protocols and lab manuals to set up new studies on Edge system, and report on laboratory capability and capacity for new studies directly to the Biochemistry Head of Research for Internal Agreement.

·         Maintain the research calendar ensuring staffing levels are suitable for future research bookings, and being responsible for own workload and liaising with R&D nurses when bookings are beyond capacity to find solutions. This requires specialist knowledge of each trial to know timeframe and sample requirements that affect capacity each day.

·         Using specialist knowledge of sample handling from GCP and IATA certifications, prepare, sort, store and arrange transportation of samples from clinical trials (complying with UN3373 regulations), including planning ahead to order dry ice to ensure samples reach central labs within required timeframes.

·         Manage and update records for all studies e.g. shipping logs, chain of custody forms, study specific documentation.

·         Responsible for laboratory R&D stock control and ordering of consumables via study specific contacts.

·         Using specialist knowledge gained from experience and certification, post holder is responsible for the training of new Research MLAs and expected to support the training of general biochemistry and reception MLAs.

·         Removal of blood, urine and faeces samples and request forms from their plastic bags and checking the corresponding data. The samples and request forms are then bar-coded prior to data entry. These samples are received from the District General Hospital, General Practice, Community Hospitals, Clinics and Community Nurses served by the Trust.

·         Perform data entry via Electronic Order Comms and typed data entry from request forms, checking that the samples received are the correct type and sufficient for the tests requested.

·         Perform duties on the urgent sample reception bench, processing many samples with specific requirements.

·         Assist with general lab stock control and replenishment/preparation of consumables for use of all staff.

·         Independently and autonomously work to deadlines, prioritising urgent tasks, and maintaining attention to detail in a busy environment where mistakes can affect patient care.

Physical skills

• Process clinical trial bloods according to strict study-specific protocols as indicated by each study lab manual and following GCP training. This may include various and complex sample processing methods that require specialist manual techniques gained through training and experience.
•  Responsible for correct handling and packaging of dry ice (IATA dangerous goods), using knowledge gained through IATA certification as to ensure no health and safety risk to self or others.
• Perform pre-analytical procedures on urine, faeces and other sample types according to lab SOPs.

Policy and service development

• Ensure ongoing compliance with ISO 14155 by maintaining up to date Good Clinical Practice (GCP) training and certification from the Nation Institute of Health and Care Research (NIHR).
• Maintain up to date IATA dangerous goods handling and shipping training and certification.
• Maintain vigilance using knowledge gained from GCP training and report any study protocol deviations to other research and development departments and/or sponsor clinical research associates.
• Ensure protocols and lab manuals being used for sample processing are up to date in line with project amendments. 

Finance, equipment and other resources

• Ensure research equipment is calibrated annually and provide R&D and sponsors with certifications when requested.
• Maintain correct fridge/freezer temperatures by responding to temperature excursions making adjustment to probes and thermostats where necessary.
• Source new equipment and consumables for new study set up, making requests for additions to UNIT4 and ensure costs are reimbursed by R&D/sponsors.
• Assist the R&D Finance Officer with filling out new study costing templates to ensure research tests are reimbursed to the correct departments. This requires broad knowledge of tests across multiple disciplines gained through extensive laboratory experience, and when completed the document must be passed to the Head of Department for approval.
• Carry out routine maintenance of pre-analytical equipment.
• Perform specific Clinical Biochemistry tests e.g. Blood Gases in accordance with Standard Operating Procedures under the supervision of Biomedical Scientists.
• Use balances and scales for preparation of samples e.g. 24-hour urines.
• Change consumables on water purification system and maintain logs.
• Maintain and clean centrifuges.
• Clean filters and defrost the -80C research freezer and maintain log.
• To operate and perform basic maintenance on the Cobas 8100 pre-analytical equipment. 

People management and training

• Assisting in the training and monitoring of new or less experienced Medical Laboratory assistant staff or trainee Biomedical Scientists

Information technology and administrative duties

• Monitor and action any emails to both personal NHS and generic research email systems
• Update and maintain all existing Microsoft Excel spread sheets for each study and set up new ones, to track study-specific information.
• Set up and update study workflows on R&D Edge system.
• Transcribing temperature excursions onto EMS temperature monitoring system, adding notes, and documenting temperature logs for sponsor CRAs.
• To package samples for dispatch to reference laboratories ensuring compliance with the postal regulations for pathological specimens. To bring to the attention of the Duty Biochemist all rejected samples due to inadequate patient details given or incorrect type of sample received for the test requested.
• Monitoring and recording of the temperature of all refrigerators and freezers containing reagents and specimens, as required by UKAS, any malfunction to be notified to a senior member of staff and report to local IT services and/or JTF wireless. Temperature excursions to be transcribed onto EMS system describing problem and action taken. Probes to be reconnected via RFID if disconnection occurs.
• To collate and enter a range of test results received from reference laboratories (approx. 100 per week) into the pathology computer system ready for authorisation by the Duty Biochemist.
• Regularly check the computer-generated outstanding work lists for missing results from reference laboratories and follow up with telephone calls to the relevant laboratory where necessary.