Note, this position is posted at WCM under the following title and requisition number: IRB Regulatory Associate (40685)
Position Summary Provides 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.
Education Bachelor'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.
Internal Number: 40685
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.