- 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
- Bachelors with 5-8 years, or masters with 3-5 years of experience
- Experience organizing and analyzing data evaluating clinical samples or efficacy of vaccines and therapeutics is desirable
- Experience working in a Quality (GxP) environment is required
- Must be able to pass health and security checks to permit work in a BSL-3 and BSL-4 laboratories with Tier 1 select agent viruses
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Tufts Medical Center Careers Boston, MA, United States Full timeWe're saving lives, building careers, and reimagining healthcare. This role focuses on providing medical and clinical support services to patients . Responsible for medical services involving the excision or incision of a patient's body, such as interventional pain management and ...
RESEARCH SPECIALIST III, School of Medicine, Microbiology - BOSTON, United States - Boston University
Description
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:
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran status.
We are a VEVRAA Federal Contractor.Required Experience
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