Clinical Research Coordinator
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 coordinator B in The Division of Gastroenterology/Department of Medicine will manage the coordination of investigator-initiated and industry-sponsored Phase I-IV clinical trials of novel therapies or currently available therapies used in novel ways, as well as prospective observational studies. These studies are expected to advance the field with the focus of helping patients. Involvement in studies will consist of serving as the primary site coordinator for a study handling all coordinator activities, including: Assisting in development of study documents; Communicating with study team members and regulatory review boards; Recruiting, consenting. and screening patients according to protocol; Scheduling patient visits and any necessary testing; Conducting patient visits; Monitor patients per protocol requirements and ensuring adherence to protocol requirements; Organizing and maintain all documentation required by the Investigator, sponsor or CRO, including source documentation, case report forms, consent forms, and research charts; Collecting, reviewing, and reporting study data; Completing case report forms and resolving data queries; Processing and shipping study specimens, including blood, stool, and urine; Participating in initiation, monitoring, audit, and close-out visits; Participate in study team meetings and ongoing protocol training; Showing vigilance in patient safety, protocol compliance, and data quality; Adhering to all University of Pennsylvania, FDA and GCP guidelines.
A Bachelor’s Degree and 2 years to 4 years of experience or equivalent combination of education and experience is required.
\Effective problem solving abilities as well as effective communication and writing skills are required.
Strong organizational and time management skills, flexibility and the ability to multi-task are very important, as is the demonstrated ability to work as part of a team, as well as independently. Knowledge of IRB and human research protection regulations is highly preferred.
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.