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Senior Clinical Research Administrator

Weill Cornell Medical College

New York, NY
Weill Cornell Medical College
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Job Details

Position Summary

Responsible for leading and driving all aspects of Clinical Research development, infrastructure administration and strategic business planning, budgets, operations and systems implementation for DGM clinical operations, regulatory affairs, data/safety management and monitoring components of Clinical Affairs\. This includes the creation and delivery of operational and technical clinical research infrastructure initiatives and plans and establishment of clinical research and development \(RandD\) milestones for Genetic Medicine \(DGM\) with little oversight\.

Job Responsibilities

+ Leads the creation of all aspects of WCM DGM Clinical Research Affairs strategic infrastructure development and administration\. Recruits, develops, and motivates high quality resources to assure timely achievement of function objectives and goals\.

+ Responsible for establishing, developing & directing the delivery of the strategic operational & technical Clinical Development Plans and programs based on innovative research methodologies, combine drug development/pharmaceutical industry knowledge\.

+ Using sound judgment to deal with complex organizational and technical challenges: lead a matrix management team to design and implement a business plan to organize project's Clinical Development Plan \(CDC\)\.

+ Spearheads the development of Investigational New Drug Applications \(IND\)\.

+ Provide for effective leadership, research staff Task Force, and resource and operational support to hospitals/departments/divisions that does IGM gene transfer clinical trials\.

+ Prepare complex written research reports and verbally present results to key stakeholders on an independent basis\. Writes clinical part of IGM grants\. Reviews and edits what other researchers write for the clinical portion of their grants\.

+ Reads clinical database for ongoing and timely visibility of measured parameters\.

+ Directs and supports regulatory affairs efforts in the development of required submissions\.

+ Assists and supports Clinical Investigators in the development of presentations and publications of the clinical study results resolution\.

+ Serves as an internal consultant to the DGM Vector Production Core for Drug Master File regulatory submissions\.

+ Leads the DGM effort in recruitment of subjects under approved protocols\.


+ Bachelor's Degree in related field


Master's degree preferred\.

Experience in monitoring multicenter clinical studies\.

Knowledge, Skills and Abilities

+ Extensive understanding of research and development process for biologic/pharmaceutical product\.

+ Strong organizational and self\-management skills\.

+ Experience in variety of audit types\.

+ Extensive knowledge of applicable gene transfer clinical research regulations and guidelines\.

Licenses and Certifications

+ Clinical Research Coordinator certificate \(CCRC\), Clinical Research Associate certificate \(CCRA\) and/or Clinical Research Professional certificate \(CCRP\) by examination necessary\.

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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