12 days old

Clinical Trials Administrator

Weill Cornell Medical College
New York, NY 10007
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Position Summary

Oversees multi\-disciplinary clinical research and related activities for specified programs and/or disease area\(s\)\. This role also manages the day\-to\-day operations, including regulatory, data management and administrative aspects for these program\(s\)\.

Job Responsibilities

+ Ensures compliance with regulatory audits/inspections and/or internal reviews\. Develops and recommends corrective action plans to address deficiencies identified\. May serve as liaison to audit team\(s\) during on\-site visits\.

+ Serves as central point person for program related matters and issues\. Provides guidance on research\-related questions within the program\. Troubleshoots potential issues and facilitates smooth clinical study operations among research team\.

+ Oversees research billing compliance for cooperative group clinical trials\. Ensures that Human Research Billing Analysis Forms \(HRBAF\) are completed in an accurate and timely fashion for all studies and are referenced and adhered to as studies progress\.

+ Serves as liaison with the Food and Drug Administration \(FDA\), as indicated, to obtain Investigational New Drug \(IND\) number or exemption\.

+ Assists leadership with developing and implementing strategies to build and grow the program's clinical research portfolio\.

+ Provides regulatory support for program and/or disease area\(s\) as necessary\.

+ Responsible for dissemination of research\-related billing information and policies to clinical trials staff and investigators\. Ensures a timely receipt of payment for studies\. Develops and maintains system to track income and charges incurred\.


+ Bachelor's Degree in related field


Approximately 3 years of experience in health\-related role, in clinical or research setting

Knowledge, Skills and Abilities

+ Experience with regulatory, data management, and billing compliance aspects of clinical research\.

+ Experience with conducting and carrying out protocols and research coordination\.

+ Familiarity with IRB interaction, regulatory policies, database input and report generation\.

+ Research experience in an academic health center with exposure to a team research environment at all levels \(senior investigators, nurses, research coordinators, lab technicians\.

Licenses and Certifications

Working Conditions/Physical Demands

Standard office work

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 Employer\. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information\.
Posted: 2019-08-06 Expires: 2019-09-06

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Clinical Trials Administrator

Weill Cornell Medical College
New York, NY 10007

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