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Weill Cornell Medicine

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1300 York Ave, New York, NY 10065, USA

5 Star University

"Research Compliance Administrator"

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Research Compliance Administrator

Position Summary

Under the direction of the Chief Research Compliance Officer, the HRP Optimization Administrator will lead Human Research Protections cross-functional continuous improvement efforts. The role is responsible for evaluating and recommending procedural changes, systemic solutions, and community materials. This role will serve as the subject matter expert in Human Subjects Research applicable regulations and will support the creation and implementation of policies.

Job Responsibilities

  • Maintains and analyzes IRB operations metrics for the WCM IRB office in support of process improvement initiatives.
  • Develops, orchestrates and conducts research training as required by the process improvement initiatives as part of the change management plan.
  • Supports internal and external quality assurance and IRB auditing.
  • Exercises independent judgement in analysis of and proactively identifies areas and strategies for improvement.
  • Facilitates internal subcommittees, e.g. policy subcommittee, process improvement, etc. to assist with building the WCM HRPP.
  • Maintains an advanced 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.
  • Manages and facilitates systemic changes to the Human Subjects module by evaluating requests across the institution.
  • Supports a community of practice for those who work to support human research protections, HRPP and IRB professionals and members.
  • Advise on institutional compliance with the terms of the OHRP Federal Wide Assurance (FWA).

Education

Bachelor's Degree

Experience

Masters Degree is highly desired. At least 5 years of direct experience in research quality assurance and process improvement, including past performance with business analysis, developing and analyzing business operations metrics in a human research office or research administration office supporting. Working knowledge of federal regulations and ethical standards for research with human subjects, i.e. common rule, FDA regulations, etc. is highly desired. Advanced knowledge of federal and New York State regulations for research with human subjects is preferred.

Knowledge, Skills and Abilities

  • Demonstrated organizational skills and ability to pay close attention to detail.
  • Ability to multi-task/handle simultaneous tasks and excellent project management skills.
  • Ability to protect confidential documents and sensitive information, using judgment and discretion in sensitive matters.
  • Excellent interpersonal, oral, and written communication skills.
  • Ability to work with limited supervision and serve as a strong team member.
  • Ability to conduct monitoring and auditing activities, including site visits, independently and competently.

Licenses and Certifications

Certified IRB Professional (CIP) REQUIRED

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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