The Griffiths group works to understand the molecular biology and pathogenesis of viruses that require maximum containment, including Nipah virus, Lassa virus, Ebola virus, and Marburg virus. This Research technician's work will involve the following:
- Develops, validates, and qualifies assays for regulated (Animal Rule/GLP) studies (10%)
- Performs and interprets data from assays associated with Animal Rule/GLP studies
- Performs real-time data review of Animal Rule/GLP study data in both hard copy and electronic format and generates and maintains study notebooks according to institutional guidelines (15%)
- Prepares documentation of data review findings and coordinates efforts to correct or clarify data within a specific time frame (10%)
- Understands departmental, organizational, and study specific SOPs as well as the study protocol governing each active study and can apply knowledge of each to evaluate study data integrity (15%)
- Assist or lead preparation of deviation reports and the completion of resulting corrective and preventative actions (20%) Assist or lead program improvement including identification of recurring deviations and/or gaps in the quality program and initiation or revision of SOPs related to the data review and QC processes followed for Animal Rule/GLP studies (15%) Participate in QA, sponsor, and/or regulatory agency (e.g. FDA) audits (5%)
- Assist with equipment management