Boston University DATA REVIEW COORDINATOR, School of Medicine, Microbiology in BOSTON, Massachusetts
The Data Review Specialist provides routine, real-time review and verification of Animal Rule/GLP study data, including all animal observation and procedure data, to ensure adherence to generally recognized good documentation practices as well as to the study protocol and applicable SOPs. The Data Review Specialist works closely with veterinary and technical staff to ensure that all corrections and clarifications are made in a timely manner. The Data Review Specialist also works closely with the Study Compliance Manager (SCM) to ensure that deviations from the study protocol and applicable SOPs are promptly reported to the Study Director/Single Point of Control and SCM for evaluation. Additionally, the incumbent is responsible for the prompt preparation of study notebooks, to include filing, pagination, and indexing of all reviewed and finalized study data.
Bachelors Degree in Science with 01-2 months of related experience, or Associates Degree with two or more years of job specific experience, or four years of directly related experience may be substituted for the educational requirements.
Highly skilled in MS Office including Outlook, Excel, PowerPoint, Word, and Teams Must be organized, detail-oriented, able to multi-task, diligent and able to communicate professionally and effectively across departments
Must be willing to develop knowledge and skills associated with quality systems based research
Experience in or familiarity with the processes and procedures associated with animal research in the high containment environment.
Experience organizing and reviewing data and maintaining study notebooks.
Experience participating in government sponsored quality audits and other inspections.
Experience developing SOPs and other quality processes.
Skills and Competencies:
Ability to excel in an environment working with members of a highly effective work team with relatively little supervision.
Knowledge of complex work routines, rules, procedures, or operations.
Clearly conveys and receives information and ideas through a variety of media to individuals or groups in a manner that engages the listener.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.