Biorepository Sample Management
Oakland-Fremont-Pleasanton Metro Area, CA
Responsible for conducting basic laboratory activities along with complete and accurate documentation of all activities in the support of registrational and non-registrational clinical trials.
This job is the first (entry level) in a series of four (4) jobs. The Scientist I must demonstrate solid laboratory techniques, thorough documentation, and high aptitude for learning the clinical validation aspects of IVD development.
- After introduction to work processes, begins to organize and conduct laboratory activities for Clinical Trials, Proficiency Testing, Sample Characterization, Panel Builds, and general exploratory testing.
- 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.
- Provides sample tracking and testing support to the Proficiency Testing Program (CAP / VQA).
- Keeps supervisor, Director / Principal Investigator, and study team informed of testing status as instructed, 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, 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 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 troubleshoot issues related to instrumentation.
- Receives general instructions; plans and executes own work.
- Supports the maintenance of laboratory inventory.