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Clinical Research Regulatory Specialist B (Abramson Cancer Center)
University of Pennsylvania
Clinical Research Regulatory Specialist B (Abramson Cancer Center)
University of Pennsylvania
 Clinical Research Regulatory Specialist B (Abramson Cancer Center) University Overview 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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. 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. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary 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 One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Position contingent upon funding. Job Description Job Description 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 One Cancer Clinical Research (OCCR) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. Contingent upon funding. The CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision, the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated site initiation documentation. Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the Regulatory Affairs Start-Up Specialist-CC will prepare and process, with minimal supervision, all initial oversight submissions for regulatory documentation through the IRB, CTSRMC, FDA and all applicable institutional regulatory review committees. In collaboration with the Regulatory Affairs 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-CC is expected to resolve, with minimal supervision, 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 Specialist post-site initiation. He/she will participate in regulatory staff meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Start-Up Specialist-CC is expected to oversee, with minimal supervision, 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. QUALIFICATIONS: Bachelor's degree preferably in a life science or human subject protection field and 3-5 years research experience or an equivalent combination of education and experience required; at least 2 years regulatory experience preferred. Experience conducting high risk biomedical research and/or oncology regulatory research experience preferred. Associated research credentialing (CCRP, CIP, etc.) preferred. The successful candidate must have effective problem solving and critical thinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; working knowledge of IRB and human research protection regulations, including ICH GCP guidelines. The successful candidate must be self-driven with heightened attention to detail. Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Candidates must have a high level of general computing ability. Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $51,824.00 - $86,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Clinical-Research-Regulatory-Specialist-B--Abramson-Cancer-Center-_JR00097253 Copyright 2024 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-52bd59143120c742a8e6c5a193c5b3df
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Internal Number: 5637972
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.
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