Do you have a passion for great science, and an authentic commitment to making a difference in the lives of patients with grievous blood-based disorders? GBT offers a fast-paced, entrepreneurial, dynamic environment. This role is an excellent opportunity to take your career to the next level -- grow, thrive and be mentored by the best. The Study Coordinator is a key and valued member of the team.
The Study Coordinator will provide operational support to preclinical toxicology research and development project.
• Serve as a study coordinator for non-GLP and GLP preclinical toxicology studies conducted at contract research organizations (CROs) and in house
• Facilitation of study quotes, maintain and review protocol outlines, etc.
• Coordinate shipping/receipt of study test article and study-related samples to appropriate CROs
• Receive study updates, data and documents, track and maintain study specific milestones
• Study Data Analysis/Reporting:
• Assist study monitors/toxicology team representatives in the collection, compilation and analysis of study data and reports, as needed
• Creation of various data tables (e.g., CTD) and documents for regulatory submissions (e.g. IND, IB) using advanced functions of MS Word, Excel and e-sub compliance software, as appropriate
• Perform QC review of regulatory documents
• Assist in maintenance of systems and databases for accuracy and completeness
• Review and process invoices for approval
• Perform other duties as assigned
• Bachelor’s degree (or equivalent experience) in Chemistry, Biology, Biochemistry or related discipline
• At least 3-5 years of pharmaceutical/biotechnology experience in the area of preclinical pharmacology or toxicology testing
• Experience in laboratory in vivo preferred
• Demonstrated knowledge of toxicology data generation, compilation and/or review
• Computer experience including Excel, Word, PowerPoint, Outlook, Project, Endnote, and Adobe Acrobat are required, with a willingness to expand computer knowledge. Database experience a plus
• Must be organized, adaptive, and detail oriented with the ability to multi-task
• Excellent organizational skills and multi-tasking abilities are required
• Proven interpersonal skills as well as strong oral and written communication skills
• An ability to be productive and successful in an intense work environment