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Regulatory Specialist

Weill Cornell Medical College

New York, NY
Weill Cornell Medical College
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Job Details

Position Summary

The Clinical research monitor, under the guidance of the Assistant Director of Human Research Compliance, will assist in the implementation and day\-to day operations of all quality assurance and improvement initiatives for the WCM, including the audits, Data Safety Monitoring Board, and education programs\.

Job Responsibilities

+ Participates in the oversight and monitoring of investigator/coordinator compliance with IRB and institutional requirements and the approved protocol\.

+ Plans, conducts, and reports internal quality audits, both routine and for\-cause, to assure adherence to local and federal requirements

+ Categorizes findings and determines when findings require immediate remedial action; tracks and follows\- up on corrective and preventive action to ensure continuing data integrity and operational compliance

+ Provides evaluations and summaries of compliance activities to the Assistant Director, and/or stakeholders within the HRPP

+ Assists with compliance training initiatives including coordinating educational sessions, writing and editing compliance manuals, and developing presentations

+ Oversee procedures with regard to performing data management activities, maintain and update computerized databases, create forms, conduct database searches and create reports for various departments listing current research protocols\.

+ Maintain records and prepare correspondence relating to problems for the DSMB and the IRB\. Conduct preliminary reviews of all IRB protocols that request the use of DSMB and forward to the chair for initial review of the Data Safety Monitoring Plan\.

+ Acts as the WCM DSMB liaison to provide assistance and information to CTSC administrators with regard to the WCM DSMB and adverse event/Unanticipated Problems reporting and procedures\.

+ Serve as ESCRO adminsitrator


+ Bachelor's Degree in related field


Minimum of three years related work experience\.

Extensive technical knowledge of the functioning of IBCs, DSMBs and IRBs, including extensive knowledge of the technical requirements of the federal regulations that govern human subjects research, adverse events reporting, state laws governing research, and WCMC policies\.

Knowledge, Skills and Abilities

+ Proficient in word processing and database applications\.

+ Knowledge of Data Safety Monitoring Board \(DSMB\) operations\.

+ Prior monitoring/auditing experience\.

+ Strong analytical and problem solving skills, excellent interpersonal and communications skills, highly organized and ability to act as a role model for staff\.

Licenses and Certifications

Working Conditions/Physical Demands

Weill Cornell Medicine is a comprehensive academic medical center that's committed to excellence in patient care, scientific discovery, and the education of future physicians in New York City and around the world\. Our doctors and scientists\-faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization\-are engaged in world\-class clinical care and cutting\-edge research that connect patients to the latest treatment innovations and prevention strategies\. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U\.S\. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey\. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork\-Presbyterian Hospital/Weill Cornell Medical Center, NewYork\-Presbyterian/Lower Manhattan Hospital, and NewYork\-Presbyterian/Queens\. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients \- the center of everything we do\. Weill Cornell Medicine is an Equal Employment Opportunity/Minorities/Females/Vet/Disabled employer\.
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