Clinical Research Monitoring Specialist Senior
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.
Job Description Summary
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/
Reporting to the Director, Abramson Cancer Center Department of Operations, Compliance and Monitoring (DOCM), responsible for scheduling, coordinating and conducting monitoring and/or auditing of all oncology studies being conducted within the Abramson Cancer Center as well as assisting with corrective actions and training related to research compliance, quality control and quality assurance. The Senior Monitoring Specialist will follow all DOCM policies and procedures as well as have a thorough understanding of federal and local policies and guidance for the conduct of clinical research.
POSITION IS CONTINGENT UPON FUNDING
BSN or BS degree in scientific or related field and 5-7 years experience or an equivalent combination of education and experience required..
Minimum of two years as a full-time clinical research monitor/auditor in addition to at least four years as a full-time clinical research nurse/coordinator is required. Working knowledge of oncology, cooperative groups, RECIST and CTCAE is necessary. Additional experience in clinical research i.e. Data Management, Project Management, Drug Safety are a strong plus. The appropriate candidate will possess a thorough knowledge of Federal Regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality Assurance; understand the application of federal, local and institutional regulations as they apply to the conduct of human subjects research. Must be highly skilled in MS Word and Excel applications, understand medical records/patient charts organization and terminology; detail oriented; excellent organizational and time management skills in a very diverse setting; ability to exercise discretion in working with highly confidential and sensitive matter; must be able to multi-task and prioritize; must be able to work under pressure and exercise mature judgment, resourcefulness and initiative. Working knowledge of oncology, cooperative groups, GLP and GMP is a plus. Applicants without the minimum qualifications will not be considered
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
Affirmative Action Statement
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.