Clinical Affairs Lab Tech I
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Description
- 1 Primary Purpose and Overall Objective of the Job:
- Contribute to the conduct of clinical trials carried out for registration purpose on new in-vitro diagnostic solutions developed by bioMérieux (reagent, instrument, software) or for regulatory compliance purpose on existing IVD solutions already on the market.
- 2 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
- 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
- Participate in the maintenance and management of the Clinical Affairs laboratory in accordance with the applicable Quality Assurance and Safety standards
- 3 Typical Studies-Experience, Skills and Qualifications:
- 3.1 Studies-Experience:
- 2/3 years of higher education in Microbiology, Biology or Biochemistry
- 3.2 Skills and Qualifications:
- Basic scientific knowledge and theoretical laboratory organizational skills
- Thoroughness, ability to perform technical demanding tasks
- Ability to work in a team and in interface with many other bioMérieux internal functions
- Ability to provide and transfer accurate information
- Ability to positively represent the laboratory and Clinical Affairs department
- 4 Scope and Resources Accountability, Typical Performance Indicators:
- Scope and Resources Accountability: Technical, operational and logistical contribution to clinical studies; Activities performed under the supervision of lab manager or an experimented and skilled Clinical Affairs Technician (level 2 or 3)
- 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 bioMérieux internal functions (GCS, Subsidiaries, SES, Export, Warehouse, R&D, ...)
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. 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 BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).