Research at GTP requires knowledge of multiple scientific disciplines including molecular and cell biology, protein biochemistry, virology, immunology, bioinformatics, and biotechnology. Our major goals are to increase scientific knowledge in gene therapy field through the use of experiments, and help develop new life-saving treatments. Research performed at GTP includes basic research, development of platform technologies, development of the vector manufacturing methods, and pre-clinical research. Translational research is carried out using cell and animal models.
The GTP Animal Models Core (AMC) is central to the GTP mission and is instrumental for the in-life phase of the assessment of gene therapeutics prior to human application. The GLP Study Manager will play in a critical role in coordination and provision of operational support to preclinical toxicology and research and development projects conducted in laboratory animals (including rodent and nonhuman primates) for the Gene Therapy Program.
Responsibilities of the Study Manager include: * Coordination of non-GLP research and GLP preclinical studies conducted in-house and at Contract Research Organizations in laboratory rodents and large animals (including nonhuman primates) * Ensure practices are compliant with FDA Good Laboratory Practice (GLP) and other federal, state and local regulations and guidelines (USDA, OLAW, AALAC). * Scheduling activities for preclinical studies * Receipt and communication of study updates, data, documents; ensure amendments and deviations are submitted within an appropriately defined time frame * Ensure integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials and laboratory records * Participating in the execution of laboratory animal studies by providing technical support and performing study specific procedures in the areas of anesthesia, procedures, pain management, and post-operative care as needed. * Facilitation of quotes and processing of invoices for approval * Monitoring project timelines and milestones to ensure on-time delivery of projects * Maintaining study protocols, outlines, and in-life data * Organize, tabulate, and analyze data and laboratory records * Coordination of receipt and handling of test article and study-related samples * Maintenance of a Master Schedule * Maintenance of electronic databases * Developing, preparing and managing departmental standard operating procedures * Preparation of final reports for IND filings and FDA submissions * Assisting the Director in site visits and audits of contract facilities and vendors
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class ...of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.