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Job Title: CLINICAL RESEARCH MONITORING SPECIALIST SR.
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.
A BSN or BS in scientific or related field and 5 years to 7 years of experience including a minimum of two years as a full-time clinical research monitor/auditor and at least three years as a full-time clinical research nurse/coordinator or an equivalent combination of education and experience required. Additional experience in clinical research (i.e. Data Management, Project Management, Pharmacovigilence) is a 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.