Clinical Research Coordinator B/C

Location
Pennsylvania, United States
Posted
28 Oct 2018
End of advertisement period
28 Dec 2018
Ref
40-30202
Contract Type
Fixed Term
Hours
Full Time

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/

Coordinator B: With minimal supervision, coordinate Phase I-IV clinical trials. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, Participate in initiation, monitoring, audit and close-out visits, Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings, Assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality. Assist in the monitoring of external sites and assist in the management of multisite trials. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Coordinator C: Independently manage Phase I-V complex clinical trials, mentor coordinators and research assistants, consent and screen patients according to protocol. Schedule patient visits and any necessary testing, Monitor patients per protocol requirements and ensure adherence to protocol requirements, Organize and maintain all documentation required by the sponsor or CRO – includes source documentation, case report forms, and research charts. Collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples. Participate in initiation, monitoring, audit and close-out visits, Participate in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings, Assist in the development/maintenance of study specific case report forms and source document tools. As needed, monitor external research sites and manage various aspects of multisite trials. Show vigilance in patient safety, protocol compliance and data quality. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

Position is contingent on continued funding.

Coordinator B: Bachelor’s degree and 2-4 years of related experience or an equivalent combination of education and experience required.

Coordinator C: Bachelor’s degree and 4-6 years of related experience or an equivalent combination of education and experience required.

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge ofiRB and human research protection regulations.

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.