The Regulatory Assistant (RA) will directly support the Assistant Director, Regulatory Affairs in the Department of Orthopaedic Surgery. The RA will provide administrative support for regulatory compliance activities related to the department’s clinical trials portfolio. Duties include but are not limited to: * Prepare study documents for IRB submission, with supervision. This may include creating/editing informed consent forms, protocols, recruitment materials, etc. * Assist with submissions to IRB and other clinical research oversight committees * Assist with the completion/collection of essential documents as needed (e.g. 1572s, financial disclosures, etc.) in collaboration with assigned CRC * Organize and maintain the department’s central file of Essential Documents (i.e. CVs, licenses, training certificates, etc.) * Assist with the creation and maintenance of regulatory binders for new studies (paper and/or electronic) * Create and update ClinicalTrials.gov postings and update as required/appropriate * Coordinate and schedule meetings by calendaring events, booking conference rooms, compiling and distributing agendas, and drafting meeting summaries
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.