4 days old

IRB Regulatory Supervisor

Weill Medical College of Cornell University
New York, NY 10007
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Position Summary

Under general direction, is responsible for all aspects of IRB operations and provides consultation for the development of research protocols to investigators utilizing human subjects This position is also an active member of the Institutional Review Board \(IRB\) and performs review duties as appropriate

Job Responsibilities

+ Serves as a liaison to the Clinical Study Evaluation Committee to facilitate and streamline the IRB review process\. Ensures that IRB members consider necessary regulatory requirements and considerations in their review of protocols\.

+ Attends Clinical Study Evaluation Committee \(CSEC\) meetings when appropriate\.

+ Manages the regulatory review of IRB submissions\. Determines level of review and board and regulatory associate assignment\. Is the point person for staff with escalated reviews\.

+ Serves as the subject matter expert surrounding IRB regulatory requirements, processes and procedures\. Ensures timely processing of IRB reviews\. Responsible for reviewing select expedited submissions\.

+ Facilitates IRB meetings to ensure efficiency and compliance\. Ensures appropriate action items and minutes are compliant with relevant OHRP and FDA regulations\.

+ Participates and presents at educational workshops and trainings as needed\.

+ Assists with the development of standard operating procedures\.


+ Bachelor's Degree in related field


Approximately 5 years of practical experience with the functioning of IRBs

Knowledge, Skills and Abilities

+ Practical knowledge of the federal and industry regulations that govern human subjects research and adverse events reporting\.

+ Training in Collaborative Institutional Training Initiative\- Biomedical Research\.

Licenses and Certifications

+ Certified Professional Coder Certificate \(CPC\)

+ Certified IRB Professional or Certified Clinical Research Professional is highly desired

+ Collaborative Institutional Training Initiative\- Good Clinical Practice is highly desired

+ PRIM&R Ethical Oversight of Human Subject Research and IRB 201 Training is highly desired

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: 2019-11-07 Expires: 2019-12-08

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IRB Regulatory Supervisor

Weill Medical College of Cornell University
New York, NY 10007

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