Clinical Research Coordinator

Pennsylvania, United States
03 Jun 2019
End of advertisement period
03 Aug 2019
Contract Type
Fixed Term
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.

We are looking for a highly motivated, experienced, and detail-oriented individual to manage regulatory duties for multiple sites relying on the Penn IRB of Record. This individual will be the lead coordinator on a vasculitis longitudinal study registry, as well as other studies within the Division of Rheumatology.

The primary duties of the Clinical Research Coordinator B include, but are not limited to:

  • Act as the central point of contact for multiple external sites relying on the Penn IRB of Record, obtain documentation for IRB submissions, distribute IRB approved documents, assist sites in resolving regulatory issues
  • Serve as a resource for investigators and clinical research staff on regulatory matters
  • Prepare regulatory documents for submission to the Penn IRB of Record, and all applicable regulatory review committees for multiple study sites including initial submissions, continuing reviews, amendments, modifications, and reportable events
  • Facilitate reliance agreements between relying study sites and the Penn IRB of Record
  • Recruit, screen, and enroll potential study subjects as specified per protocol. Schedule subject visits and any necessary testing/specimen collection. Monitor subjects per protocol requirements and ensure adherence to protocol requirements.
  • Process and ship blood, urine, tissue, and serum specimens.
  • Complete case report forms, enter data and resolve data queries with sponsors. Retrieve medical records from outside institutions. Position contingent upon funding.

Bachelor’s Degree and 2 to 4 years of experience in a clinical research regulatory environment or equivalent combination of education and experience required. A minimum of 2 years of clinical research/clinical trial coordinating experience is also required.

Qualified candidates must demonstrate outstanding organizational skills; excellent written and verbal communication skills; a clear attitude of customer service; and the ability to work in a fast-paced environment with time sensitive deadlines and competing priorities. Candidates must be able to work independently, function in a team environment, and build and maintain positive working relationships at all levels of the institution. Knowledge of IRB and Human Research Protection Regulations, Good Clinical Practices, the relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations, and International Conference of Harmonization Guidelines are required. Demonstrated project and time management skills are necessary. Experience and functional knowledge of FDA clinical trial regulations, specifically IND and IDE regulations, are preferred. The proper candidate is expected to have a strong foundation in clinical research regulations and operations through direct experience in the role.

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.