This unit has been a state of the art center for early drug research since 1992 and is located in the area of Brussels.
For the mother company, this is the only unit in the world that is responsible for the first research phase of new human medicines in addition to the unit in the US.
14 million is invested in this unit every year. This is necessary to guide volunteers and patients with the highest possible expertise and to process the recorded data.
The unit is therefore equipped with high-tech equipment.
The unit performs approximately 30 studies per year, which corresponds to approximately 700 patients and volunteers. For this, the unit can rely on a large database of around 30,000 volunteers.
40% of the volunteers find their way to the unit through word of mouth: 99% of the volunteers who have already participated in a study are willing to participate again.
Furthermore, collaboration within the Belgian academic network is indispensable: this contributes greatly to the uniqueness of this site.
• Perform all routine and special clinical chemistry, haematological, coagulation, and urinalysis, immunological and other tests according to the Standard Operating Procedures.
-Implement and validate new assays. May assist with assay development. Coordinates with the guidance of the Laboratory Manager new methods validation and instruments implementation.
- Perform all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control and calibration data.
- Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required during experimental procedures.
- Perform and document required routine maintenance and calibration of laboratory instruments.
- Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
- Process samples for analysis or storage. Utilize PIMS/LIMS computer system for the processing of samples.
• Collect biological samples from study subjects. Process samples for analysis and storage. Oversee the specimen storage inventory.
• Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
- Train and or mentor personnel in laboratory procedures as assigned.
- Perform data entry and monitor laboratory information management system (LIMS).
- Recognize and correct any improperly functioning instruments or inaccurate test procedures in timely fashion by following through and communicating with other personnel and manufacturer of instruments.
- Maintain clean and safe work areas per SOP.
- Write new or revise procedures for the SOP or Manuals as assigned.
• Instrument Owner: Performs monthly QC report and reviews with Laboratory Quality Coordinator. Maintains reagent and consumable inventory. Performs lot to lot QC comparison and sets QC ranges. Schedules preventative maintenance. Monitors that maintenance is performed. Reviews SOPs yearly for relevance and documents review.
• Assists the Laboratory Manager with the Laboratory Quality Coordinator and Improvement Plan by identifying pertinent quality goals, plans and procedures for measuring and monitoring quality, procedures for responding to insufficient quality and for improving quality by documentation and development. Implementation of Corrective Actions/ Preventive Actions /Immediate Actions if needed.
• Assist the Laboratory Quality Coordinator with preparation for Internal audits and BELAC audits.
• Performs Biomarker testing as assigned. QC and analyze the data produced from analysis. Document all analysis on appropriate assay check sheets.
• Will perform continuing education as assigned
• Will do EQA (external quality assessment)/ proficiency sample testing as assigned
• Will bring any issue of noncompliance to the attention of Lab Quality Coordinator or the Lab Manager and act to rectify the situation.
• Monitors emails and voicemail to respond in an appropriate time frame.
• Investigate any possible sample integrity issue and ensures that it is rectified.
• Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits, check-ins, and discharges late.
• Open communication with other departments in the building
• Work as a team with Lab staff and staff
• Be able to function autonomously.
• Perform critical problem solving
• Any additional projects assigned by the supervisor.
• Minimum of a bachelor degree (Life Science/Biomedical or Health Care related training).
• Experience with Cobas/Sysmex platforms is a must.
• Minimum of one year of laboratory experience performing either clinical chemistry, hematology, immunoassay, coagulation, and/or urine analyses. Two to three years’ experience preferred.
• Agreement/authorization to practice Laboratory Technician profession.
• Experience/knowledge in ISO15189 or ISO 17025 guidelines is a plus.
• Experience with managing projects, be well organized
• Good verbal and written communication skills.
• Good written and verbal skills in English is essential, French and/or Dutch is an asset
• Basic working knowledge of laboratory information system and computer software such as Excel, Outlook, Word and PowerPoint
• Ability to work in a team environment
• Be results oriented and quality oriented
• Thorough understanding and demonstrated proficiency in handling laboratory projects
• Scientific/Clinical Research Knowledge
- knowledge of our clinical & analytical Laboratory environment is a plus
- demonstrated understanding of the complexities and recent developments in Biomarker/exploratory research.
- challenges existing paradigms in clinical research and encourages novel designs/ideas and research approaches; works to improve study conduct, data capture and retrieval and submission processes