Note, this position is posted at WCM under the following title and requisition number: IRB Regulatory Associate (40685)
Position SummaryProvides administrative, operational and regulatory support to Weill Cornell Medicine (WCM) IRBs and Human Research Protection Program (HRPP).
Job Responsibilities-Processes human research submissions, including conducting basic pre-reviews of human research studies to ensure regulatory and institutional compliance.-Communicates with researchers and research staff to address questions/concerns; provides technical and regulatory support and guidance as needed.-Assists with preparing 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 serves as liaison between members and researchers.-Assists with conducting outreach efforts with assigned WCM departments and/or divisions, and serve as the primary point of contact.-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.EducationBachelor's Degree in related field
Knowledge, Skills and Abilities-Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise "people skills".-Demonstrated proficiency with MS Office Suite and database applications.-Demonstrated organizational skills and ability to pay close attention to detail.-Demonstrated critical thinking and analytical skills.-Demonstrated ability to multi-task and prioritize in a fast-paced environment.-Demonstrated ability to remain focused despite frequent interruptions.-Ability to treat confidential information with utmost discretion.-Demonstrates ability to exercise standards of professionalism, including appearance, presentation and demeanor.-Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
Experience-Approximately 1 year of experience working in an IRB office, research administration, or supporting human research activities OR a combination of completed education and experience.
-Certification as an IRB Professional (CIP) preferred.
-Working knowledge of research administration and IRB database systems preferred.
-Working knowledge of federal regulations and ethical standards for research with human subjects, i.e. common rule, FDA regulations, etc. preferred.
-Experience conducting or reviewing biomedical and social/behavioral research with human subjects preferred.