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.
Posted Job Title
Clinical Research Monitoring Specialist
Job Profile Title
Clinical Research Monitoring Specialist
Job Description Summary
Clinical Research Monitoring Specialist will work as part of the Compliance team to help support and facilitate clinical research at the University of Pennsylvania.
The Clinical Research Compliance Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director, PSOM Clinical Research Audit and Compliance. The incumbent will work with senior team members to facilitate and conduct high quality compliance reviews, which include review preparation, conduct, close out and reporting, to ensure compliance with federal regulations and institutional policies. This position will interface with research investigators and staff throughout the review process. In addition to compliance reviews, this position will assist in the development of protocols, informed consents, case report forms, and other study documentation for Principal Investigators as needed. Within the OCR, the Clinical Research Compliance Specialist will interface with other OCR units to ensure the best support of research regulatory requirements, to assist with OCR research educational initiatives and to participate in research staff training.
Experience in the following areas preferred: - Compliance oversight for clinical trials; monitoring or auditing of studies - Coordination of clinical research studies - Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines - Ability to respect and protect highly sensitive and confidential information
Bachelor's degree and 3 to 5 years experience or equivalent combination of years and experience required.
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: JR00003110
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.