Clinical Research Monitoring 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.
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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 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.
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