4300 Hacienda Drive Pleasanton, CA 94588
- Works under general supervision, to support aspects of panel build and sample processing projects adhering to required standards to produce Test Panels and Sample Sets for use in Clinical Validation Studies.·
- Supports the laboratory’ s participation as a Clinical Testing Site through performing Clinical Validation testing and the accurate completion and filing of all applicable documentation in compliance with Protocols, IRBs, Manuals of Operations, Test Instructions, and related Code of Federal Regulations and ICH guidelines.·
- Keeps supervisor/project leader informed of project status, particularly of significant findings and results in critical problem areas.·
- Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA)· Critically evaluates quality control and test results against acceptance criteria to support project decisions.·
- Uses technical writing skills and Good Documentation Practices to complete project documentation and produce reports and documents. May present findings at internal meeting.·
- Assumes accountability for own project documentation, ensuring applicable methods and results are recorded timely, accurately and consistently, and according to established formats.·
- Participates in routine lab maintenance, lab safety, ISO, and QSR implementation.·
- May perform basic troubleshooting for issues related to instrumentation.· Receives general instructions; plans and executes own work.·
- Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions·
- May establish and work with individuals or teams outside of immediate functional area or RMD.
- Experience:· 0 years required, 1 year preferred of relevant industry experience, including experience in participating clinical research work within a laboratory· Required minimum 2 years of basic laboratory experience in either academic or industry setting.Knowledge, Skills, and Abilities:·
- Experience documenting detailed Clinical Trial activities in Case Report Forms, Sample Accountability and Investigational Material Accountability Logs
- Formal Training/Education:· Bachelor’s degree in Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.