Description
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 A (Department of Otorhinolaryngology)
Job Profile Title
Clinical Research Regulatory Specialist A
Job Description Summary
The Clinical Research Regulatory Specialist position will assist in maintaining regulatory compliance for the Department of Otorhinolaryngology. The RAS will provide regulatory support and expertise associated with clinical trials. The person will support a diverse group of investigators and coordinators involved in a broad spectrum of clinical trials. Involvement will range from consulting to serving as the primary regulatory contact for a study, handling all regulatory submissions, regulatory binders, monitor visits, and compliance checks.
With minimal supervision, the Clinical Research Regulatory Specialist will prepare and process all regulatory documentation through the IRB, CTSRMC, etc., and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. With minimal supervision, they will prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations (CROs), etc., and organize and maintain all regulatory affairs documentation/files as needed. The Clinical Research Regulatory Specialist is expected to resolve regulatory and data queries as required and participate in initiation, monitoring, audit, and close-out visits. They will participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Clinical Research Regulatory Specialist is expected to facilitate the development of grant and clinical trial submission of applications and annual reports, development/maintenance of study-specific case report forms and source document tools, provide direct regulatory/compliance guidance, and facilitate investigator-initiated multi-site trials-additional duties relevant to regulatory affairs as assigned.
Job Description
Clinical Research Regulatory Affairs Specialist A
Assist in Clinical Trial proposal submissions.
Provides day-to-day oversight and coordination of the credentialing information for study-associated faculty, research nurses, research coordinators, and ancillary support staff, including credentials such as GCP, HSP, CV, clinical licensure, and profile information.
Assist in serious adverse events are reported to sponsors and Clinical Research Organizations (CROs). Regulatory work with Institutional Review Board (IRB), Clinical Trials Scientific and Monitoring Committee (CTSRMC), and other entities.
Assist in maintaining regulatory compliance across the department.
Qualifications
A High School diploma and 2 years of experience or an equivalent combination of education and experience are required. A bachelor's degree is preferred.
The position is contingent on continued funding.
Working ConditionsOffice, Library, Computer Room: Exposure to Chemicals Requires extensive safety. Physical EffortTypically sitting at a desk or table, Occasionally lifting 25 lb. or less.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$23.06 - $23.06 Hourly 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.
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.
University Benefits
Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If
Compensation Information:
$23.06 / Hourly - $23.06 / Hourly
Starting At: 23.06 Hourly
Up To: 23.06 Hourly
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