GLP STUDY COORDINATOR
University of Pennsylvania

Job Info

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Duties: 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

Qualifications: 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

Reference Number: 40-29796

Salary Grade: 027

Employment Type: Exempt

Org: DM-Gene Therapy Program

Special Requirements:

Job Family: I-Technical/Professional Research

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