Clinical Research Operations Specialist
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.
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 Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/
The Clinical Research Operations Specialist is an integral part of the Operations Unit in the Office of Clinical Research (OCR). Under the direction of OCR’s Senior Director of Clinical Research Operations, this position’s primary role is to serve as business analyst and quality assurance specialist for the Penn Clinical Trial Management System (CTMS) application. This position will read and analyze research data protocols and fulfill data entry in the Clinical Trial Management System platform; will generate reports and metrics for senior and departmental leadership; will lead user acceptance testing and provide recommendations concerning Penn CTMS; will develop relationships with industry partners, commercial clinical research orgs. , Penn Medicine faculty and staff to facilitate clinical research; and will assess education and training needs on an individual, unit and departmental level based on newly implemented clinical research support platforms. This position will be involved with data entry, CTMS direction setting and quality assurance and analytic functions around the CTMS application.
The minimum of a Bachelor’s degree and three to five years experience in clinical/translational research operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) or an equivalent combination of education and experience required. Master’s degree preferred.
Direct experience in the following areas:
Clinical research coordination or project management, Ability to read and operationalize clinical research protocols, Direct experience generating consent forms and other clinical research supporting documents, Development and implementation of clinical research education programs
- Demonstrated knowledge of GCP/OHRP/FDA/HIPAA regulations
- Ability to take initiative and think strategically
- Demonstrated ease and comfort working with a wide range of personnel
- Excellent communication and effective writing skills Previous experience with Clinical Trial Management tools, especially Velos application preferred
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.