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 Pennâ™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 Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 14 Research Teams that support disease/discipline specific cancer programs within the ACC.
The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Start-Up Specialist to independently facilitate the regulatory aspects of the initiation of Phase I-IV clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Â Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Start-Up Specialist will prepare and process all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration with the Regulatory Administrative Coordinator, he/she will prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), the NCI and the FDA, as well as, organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start-Up Specialist is expected to resolve regulatory queries, and participate in the initiation of the new study, as well as, communicate transition of the new study to the applicable team Regulatory Affairs Coordinator post-site initiation.Â He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Start-Up Specialist is expected to oversee the development of investigator-initiated research protocols, the development and submission of FDA IND applications, and the development of study specific forms and source document tools, as well as, to provide direct regulatory/compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site trials.
THIS POSITION IS CONTINGENT UPON FUNDING
Primary Work Location address is 3930 Market Street, Secondary work location is address Perelman Center For Advanced Medicine 3100 Civic Center Blvd.
The successful candidate must possess effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; be flexible and able to multi-task; have a demonstrated ability to work as part of a team, as well as independently; and maintain adequate knowledge of IRB and human research protection regulations.
Regulatory Affairs New Study Start Up Specialist:
To work on NCI/NCTN and Phase II/III industry sponsored trials with minimal supervision.
Regulatory Affairs Specialist : Bachelorâ™s degree required and 3-5 years of related experience (or equivalent combination of education and experience).
Regulatory Affair New Study Start Up Specialist Sr:
To work on NCI/NCTN and Phase II/III industry sponsored trials independently.Â To also work on Phase I industry sponsored trials and investigator initiated protocol development with minimal supervision.
Regulatory Affairs Specialist, Senior : Bachelorâ™s degree required and 5-7 years of related experience (or equivalent combination of education and experience).Â
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: JR00010880
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.