Note, this position is posted at WCM under the following title and requisition number: Senior IRB Regulatory Associate (48181)
Functions as the lead associate within the respective regulatory team to support the regulatory and research oversight function of the Weill Cornell Medicine (WCM) IRBs and Human Research Protection Program (HRPP).
-Processes complex IRB submissions (biomedical and social/behavioral human research studies), including conducting regulatory pre-reviews of human research studies to ensure regulatory and institutional compliance.
-Exercises independent judgement in the determination for regulatory requirements.
- Communicates with researchers and research staff to address questions/concerns; provides technical and regulatory support and guidance as needed.
-Provides technical and regulatory support and guidance to researchers and research staff; ensures all WCM institutional requirements are addressed/complete.
-Prepares IRB meeting agendas, attends IRB meetings, generates correspondence/regulatory documents from meetings and drafts meeting minutes in accordance with federal regulatory requirements.
-Works closely with IRB members (WCM faculty and unaffiliated members) to address respective research review concerns and serve as liaison between members and researchers.
-Conducts outreach efforts (training, regulatory guidance, etc.) with assigned WCM departments and/or divisions, and serves as the primary point of contact.
-Serves as a non-supervisory backup for regulatory managers, as needed. For example, administers board meetings and ensures meeting agendas meet regulatory requirements, etc.
-Serves on internal subcommittees, e.g. policy subcommittee, process improvement, etc. to assist with building the WCM HRPP.
-Maintains a current and working knowledge of federal, state and local regulations and institutional policy and procedures to ensure the WCM IRBs and HRPP are in compliance with applicable mandates.
-Performs other related duties as assigned.
-Approximately 3 years of experience working in an IRB office, research administration, or supporting human research activities or at least five years of experience (with no degree).
-Working knowledge of federal regulations and ethical standards for research with human subjects, i.e. common rule, FDA regulations, etc.
-Certification as an IRB Professional (CIP) is highly desired.
-Advanced knowledge of federal and New York State regulations for research with human subjects is preferred.
-Experience conducting or reviewing biomedical and social/behavioral research with human subjects is preferred.
Knowledge, Skills and Abilities
-Detail oriented and superb organizational skills.
-Effective oral and written communication skills.
-Demonstrated critical thinking and analytical skills.
Internal Number: 48181
About Weill Cornell Medicine
Weill Cornell Medicine is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. Since 1898, our doctors and scientists have been engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies.