Overview
Clinical Biochemistry performs analyses on a range of biological samples (blood, urine, faeces, fluids and cerebrospinal fluid) to aid diagnosis and treatment using Departmental SOPs and protocols. The Department processes approximately 450,000 requests and generates over 5,000,000 tests annually with a total budget of £1.9 million. Services cover main automation (Roche Managed Service), special chemistry/protein electrophoresis and Point of Care (POCT). The department also supports Torbay and South Devon Research and Development in clinical trials and projects. This is a challenging and varied role with opportunities to influence patient outcomes through innovation and science.
About Us
Clinical Biochemistry is essential to the secondary and acute care pathways of the Trust, providing a 24/7 diagnostic service using automation and specialised techniques.
Job Responsibilities
- Using specialist knowledge, prepare and process samples adhering to strict and complex study-specific protocols and lab manuals for Research and Development coordinated clinical trials.
- Represent the laboratory at study site initiation visits, review and set up new studies, and report laboratory capability and capacity to the Biochemistry Head of Department.
- Handle telephone and email enquiries from R&D and external sponsors, addressing technical and investigational queries, protocol deviations, missing samples, and providing specialist advice.
- Organise storage, packaging and daily dispatch of samples nationally and internationally with couriers.
- Complete delegation and training logs in line with ongoing specialised study-specific training and protocol amendments.
- Maintain communication with internal research departments and external sponsors through Clinical Research Associates.
- Provide technical and clerical assistance alongside Biomedical Scientists and other staff to support clinicians in diagnosis and treatment.
- Prepare routine and urgent blood, urine, faeces and fluid samples for analysis.
- Support the out-of-hours rota and evening work as required.
Planning, Organisation and Compliance
- Review protocols and lab manuals to set up new studies; report laboratory capability and capacity for new studies.
- Maintain the research calendar and ensure staffing levels are suitable for future bookings; liaise with R&D nurses to resolve capacity issues.
- Handle sample transport in compliance with UN3373 regulations; order dry ice as needed.
- Manage and update study records (shipping logs, chain of custody, study documentation).
- Oversee laboratory R&D stock control and consumables procurement.
- Train new Research MLAs and support training of general biochemistry and reception MLAs.
- Process and data-entry samples from various sources; perform duties on the urgent sample reception bench.
Physical Skills
- Process clinical trial bloods according to study-specific protocols and GCP training; perform complex sample processing.
- Handle and package dry ice safely (IATA) to prevent health and safety risks.
- Perform pre-analytical procedures on urine, faeces and other sample types per SOPs.
Policy and Service Development
- Maintain ISO 14155 compliance and up-to-date GCP training and NIHR certification.
- Maintain IATA dangerous goods handling and shipping training; report protocol deviations as required.
- Ensure protocols and lab manuals are up to date with project amendments.
Finance, Equipment and Other Resources
- Ensure equipment is calibrated annually and provide certificates on request.
- Maintain temperature controls for fridges/freezers and adjust probes/thermostats as needed.
- Source equipment and consumables; manage costs with UNIT4 and sponsor reimbursements.
- Assist with study costing templates to ensure reimbursements; obtain approval from the Head of Department.
- Maintain pre-analytical equipment and assist with routine maintenance and basic operation of Cobas 8100 pre-analytical equipment.
People Management and Training
- Assist in training and monitoring of new or less experienced Medical Laboratory Assistants or trainee Biomedical Scientists.
Information Technology and Administrative Duties
- Monitor NHS and research email systems; maintain and update study spreadsheets and workflows on the R&D Edge system.
- Record temperature excursions on EMS; package samples for dispatch in accordance with postal regulations; report rejected samples due to missing details or incorrect sample type.
- Monitor and record refrigerator/freezer temperatures; report malfunctions to senior staff and IT services; transcribe temperature data to EMS with notes.
- Collate and enter results from reference laboratories (approx. 100 per week) for authorisation by the Duty Biochemist.
- Regularly review outstanding work lists and follow up as needed.
Person Specification
Qualification and Training: Essential – Good general education/A levels/NVQ level; Desirable – GCP certification; IATA certification.
Knowledge and Experience: Essential – IT/Computers, Health and Safety, ability to work independently or as part of a team, good communication and interpersonal skills, good telephone manner, ability to work under pressure; Desirable – experience with laboratory automation, LAB information systems (Epic Beaker, IHCS, ICE), and ethics/data protection in clinical trials.
Specific Skills: Essential – ability to organise own workload, initiative, enthusiasm, conscientiousness, strong communication, and manual techniques with precision equipment; Desirable – NHS lab experience, sample processing/reception, clinical trials experience.
Additional Information
Disclosures: This post requires DBS check under the Rehabilitation of Offenders Act 1975; includes Sponsorship considerations for Skilled Workers (UK Visas and Immigration). See guidance on overseas criminal records checks as applicable.
Employer: Torbay and South Devon NHS Foundation Trust, Clinical Biochemistry, Level 3, Torbay Hospital, Torquay, TQ27AA. Website: https://www.torbayandsouthdevon.nhs.uk