Clinical Affairs Lab Tech 2

bioMerieux Inc.
United States, Missouri, Hazelwood
595 Anglum Road (Show on map)
Nov 13, 2024
Clinical Affairs Lab Tech 2 Location: Hazelwood, MO, United States Position Type: Unfixed Term Job Function: Clinical Affairs Share: share to e-mail Share on Facebookshare to facebook Tweetshare to twitter Share on LinkedInshare to linkedin Apply Now > A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture. Description Contribute to the conduct of clinical trials carried out for registration purpose on new in-vitro diagnostic solutions developed by bioMerieux (reagent, instrument, software) or for regulatory compliance purpose on existing IVD solutions already on the market. Main Accountabilities: Carry out the experiments and tests required for clinical studies of simple to moderate complexity, while respecting the study protocol and its requirements, the timelines and all applicable Quality Assurance and Safety standards Carry out the experiments and tests required as part of the validation of the instruments and their configurations in accordance with the study protocol and its requirements Provide accurate, high quality test results and reliable data Document and record all activities to ensure traceability and quality of the clinical studies conducted Contribute to the preparation of clinical studies carried out on external sites in Europe by managing all logistical, administrative, operational and technical activities: ordering of materials, preparation of biological materials (samples and strain sets), shipments to external sites, tracking of supplies, management of instrument configurations and qualifications on site, follow-up of instrument calibration and maintenance Contribute to site visit and study set-up on external sites in Europe by providing technical training to site operators for instrument, reagent, testing and data management in accordance with the study protocol Provide Level 1 support to external sites by managing complaints and technical problems observed during the conduct of clinical studies Participate in the maintenance and management of the Clinical Affairs laboratory in accordance with the applicable Quality Assurance and Safety standards Typical Studies-Experience, Skills and Qualifications: Studies-Experience: 2/3 years of higher education in Microbiology, Biology or Biochemistry Minimum 2 years of laboratory experience Skills and Qualifications: Scientific knowledge and advanced organizational skills (laboratory reference techniques, norms and standards for the conduct of experiments and tests) allowing an autonomous realization of technical tasks Thoroughness, ability to perform complex and technical demanding tasks Ability to work in a team and in interface with many other bioMerieux internal functions Teaching skills to transfer technical knowledge to peers in Europe (training of operators on external sites) Ability to positively represent the laboratory and Clinical Affairs department outside bioMerieux Scope and Resources Accountability, Typical Performance Indicators: Scope and Resources Accountability: accountable for technical, operational and logistical support to clinical trials within the scope of his/her perimeter Financial Indicators (revenue, budget, etc.): Not applicable Key Performance Indicators (KPIs): Absence of major delays and of critical deviations impacting the quality of clinical studies Key Contacts (internal/external) and Interfaces: Collaborative work with all Clinical Affairs co-workers (CS, DM); Several interfaces with multiple bioMerieux internal functions (GCS, Subsidiaries, SES, Export, Warehouse, R&D, ...); Frequent interactions with peer functions within external sites in Europe. Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS). 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