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Posted Job Title
GLP Study Coordinator
Job Profile Title
Manager Research Project A
Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the "go-to" organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
Our Program for Comparative Research is looking for a GLP Study Coordinator, which will ensure Good Laboratory Practices (GLP) are being utilized in IND enabling in vivo studies. As a GLP Study coordinator, you will be coordinating/scheduling non-GLP research and GLP preclinical in vivo studies involving rodent and large animal models, including NHP. You will be responsible for ensuring practices are compliant with FDA, 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, ensuring the integrity of data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials and laboratory records; monitoring project timelines and milestones to ensure on-time delivery of projects; maintaining study protocols, outlines, and in-life data; and preparing final reports for IND filings and FDA submissions.
Bachelor's degree in Chemistry, Biology, Biochemistry or related discipline and at least 3-5 years of pharmaceutical/biotechnology experience in the area of preclinical pharmacology or toxicology testing performed under Good Laboratory Practices (GLP; 21CFR, Part 58) or an equivalent combination of education and experience required. Master's degree preferred.
The successful candidate should have strong experience with the management of GLP animal studies and have strong technical lab experience. The candidate should be a highly motivated individual with good communication skills, record keeping skills, computer skills with the ability to analyze and solve problems.
Demonstrated knowledge of toxicology data generation, compilation and/or review.
Knowledge and experience working with GLP toxicology; Microsoft Excel, Word, PowerPoint, Exchange; Knowledge and use of project management and database software is a plus.
An ability to be productive and successful in an intense work environment.
Highly organized and result-oriented.
Problem solving and critical thinking skills Excellent interpersonal skills.
Job Location - City, State
Department / School
Perelman School of Medicine
$50,684.00 - $91,232.00
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00005010
About University of Pennsylvania
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.