Clinical Research Monitoring Specialist

Pennsylvania United States
11 Oct 2018
End of advertisement period
11 Dec 2018
Contract Type
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.

The Center of Cellular Immunotherapies is hiring a Clinical Research Monitoring Specialist. Position will conduct initial, interim and close out monitoring visits per data safety monitoring plan, to ensure all data entered into the CRF is accurate and complete. Confirm documentation pertaining to investigational product administration and chain of custody. Review initial and follow up of all Serious Adverse Events, Medwatches, and Adverse Events. Assure the site subject and regulatory files are complete. Complete visit reports and follow up letters. Work with Project Manager during study start up and site initiated visits.

Bachelor’s degree and 3-5 years of experience as a monitor, research nurse, research coordinator or project manager or an equivalent combination of education and experience required. Clinical research experience is preferred. Experience as a monitor/auditor is a plus. A strong knowledge of GCP as well as federal, local, and institutional guidelines. Understanding in medical knowledge/patient records and terminology as well as detail oriented is 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.