Clinical Research Monitoring Specialist Senior (Cancer Center)
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Posted Job Title
Clinical Research Monitoring Specialist Senior (Cancer Center)
Job Profile Title
Clinical Research Monitoring Specialist Senior
Job Description Summary
The Abramson Cancer Center Department of Operations, Compliance and Monitoring (DOCM) is seeking a clinical research monitor/auditor to support our clinical research mission. The monitor/auditor is responsible for scheduling, coordinating and conducting monitoring and/or auditing of 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 monitor/auditor 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.
Job Description
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. Applicants without the minimum qualifications will not be considered. HUMAN SUBJECTS CLINICAL RESEARCH EXPERIENCE IS A MUST.
Qualifications:
Bachelor's degree and 5-7 years of experience or an equivalent combination of education and experience required.
RN/BSN or BS in scientific or related field preferred. Minimum of seven years of experience as a clinical research monitor/auditor, research nurse or research coordinator with at least three years' experience directly monitoring/auditing or five years' experience preparing for and fully supporting monitoring/auditing visits preferred. Working knowledge of oncology, NCTN cooperative groups, RECIST and CTCAE is preferred but not required. Additional experience in clinical research i.e. Data Management, Project Management, Drug Safety are a strong plus.
Flexible work arrangements are available, however, qualified candidates are required to commute to Philadelphia multiple times a month to meet job demands.
THIS POSITION IS CONTINGENT UPON FUNDING
Job Location - City, State
Philadelphia, Pennsylvania
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.
Department / School
Perelman School of Medicine
Pay Range
$61,046.00 - $90,000.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
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.
Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
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