New York, NY, 10176, USA
4 days ago
Senior IRB Analyst
Title: Senior IRB Analyst Location: Upper East Side Org Unit: General Research Compliance Work Days: Weekly Hours: 35.00 Exemption Status: Exempt Salary Range: $77,800.00 - $87,100.00 *As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices **Position Summary** Functions as the lead analyst 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). **Job Responsibilities** + Conducts regulatory and administrative reviews of Exempt, Expedited and Full Board submissions. Executes a high volume of complex reviews effectively and efficiently. + Critically applies knowledge of ethical, regulatory, legal, and institutional guidelines for each submission. + Has ability to independently assess submissions for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) in accordance with Federal regulations and ethical standards. + Provides guidance and consultation to investigators and clinical research personnel about WCM IRB policies and procedures. + Evaluates new submissions and works collaboratively with investigators and research personnel on required changes to secure IRB approval of submitted protocols. + Attends IRB meetings and acts as voting member as needed. + Adheres to turnaround times for review and processing activities; identifies opportunities for improvement; participates in process improvement activities; implements requested changes. + Participates in regional and national conferences and educational events. + Provides regulatory and ethical consults for investigators and research personnel on human subjects research related issues. + Oversees IRB meetings, including making assignments to staff and Board members, obtaining quorum for the meeting and providing regulatory guidance at the meeting and writing minutes. + Works with IRB leadership to review, develop and implement policies and procedures. + Works with IRB leadership to develop and present educational initiatives for the research community on applicable IRB policies, procedures, federal and state regulations and ethical principles + Provides mentorship to IRB Associates and IRB Analysts. + Researches new and emerging human research subject's issues, as well as issues for which there are different interpretations and application, as needed. + Performs other related duties as assigned. **Education** + Bachelor's Degree **Experience** Approximately 3 years of IRB regulatory experience or research management experience. Working knowledge of federal regulations and ethical standards for research with human subjects, i.e. common rule, FDA regulations, etc. Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP) 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. + Excellent communication skills (both verbal and written). + Demonstrated critical thinking and analytical skills. + Demonstrated proficiency with MS Office Suite and database applications. + 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. + Demonstrated 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. **Licenses and Certifications** + Incumbent will be expected to take the Certified IRB Professional (CIP) exam within two years of hire date. WCM will pay for the exam. **Working Conditions/Physical Demands** Cornell welcomes students, faculty, and staff with diverse backgrounds from across the globe to pursue world-class education and career opportunities, to further the founding principle of “any person, any study.” No person shall be denied employment on the basis of any legally protected status or subjected to prohibited discrimination involving, but not limited to, such factors as race, ethnic or national origin, citizenship and immigration status, color, sex, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law. Cornell University embraces diversity in its workforce and seeks job candidates who will contribute to a climate that supports students, faculty, and staff of all identities and backgrounds. We hire based on merit, and encourage people from historically underrepresented and/or marginalized identities to apply. Consistent with federal law, Cornell engages in affirmative action in employment for qualified protected veterans as defined in the Vietnam Era Veterans’ Readjustment Assistance Act (VEVRRA) and qualified individuals with disabilities under Section 503 of the Rehabilitation Act. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law.
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