IRB Regulatory Associate
IRB Regulatory Associate (40685)
This role has the option to be 100% remote.
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.
The WCM IRB is an appropriately constituted group whose primary responsibility is to ensure that the rights and welfare of human subjects in research are protected. In doing so, the IRB must ensure all human subject research activities are conducted ethically, and in compliance with Federal regulations, the requirements of applicable New York State and local law, and institutional policies and procedures. In accordance with the Common Rule and FDA regulations, the IRB has responsibility for approving, modifying, and/or disapproving human subject research. The IRB also has the authority to suspend or terminate research in order to protect research subjects and for noncompliance with applicable rules and regulations.
The IRB Regulatory Associate provides administrative, operational and regulatory support to Weill Cornell Medicine (WCM) IRBs and Human Research Protection Program (HRPP).
Some 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.
Education: Bachelor's Degree in related field
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; and Experience conducting or reviewing biomedical and social/behavioral research with human subjects preferred.
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.
To apply, please visit
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.