GLP Study Coordinator
1 day left
- Full Time
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
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
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.