Senior IRB Regulatory Associate
Senior IRB Regulatory
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 Senior IRB Regulatory Associate 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).
Some Job Responsibilities:
- 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.
Education: Bachelor's Degree in related field
Experience: 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; and 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.
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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.