Institutional Review Board Specialist - New York, United States - NYU Langone Health

NYU Langone Health
NYU Langone Health
Verified Company
New York, United States

2 weeks ago

Mark Lane

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Mark Lane

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Description

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity, diversity, and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace diversity, inclusion, and individual skills, ideas, and knowledge. _For more information, go to , and interact with us on _LinkedIn_, _Glassdoor_, _Indeed_,_ _Facebook_, _Twitter_ and _Instagram_._


Position Summary:

We have an exciting opportunity to join our team as a Institutional Review Board Specialist.


Reporting to the Senior Scientific Manager Full Board (SSM) of the IRB, the Specialist is responsible for the efficient pre-review of full board modification and continuation submission action items from submission until board review within expected turnaround time, assists with minutes preparation, and performs initial study submission review as needed.

The pre-review specialist also provides vacation and sick leave coverage to other Senior Specialists and a Full Board Sr Analyst.


Responsibilities:


  • Reviews and analyzes continuing review submission documents (protocol, consent and other relevant documents) for completeness consistent with federal and state regulation, institutional requirements, and HRP policy, and communicates all identified deficiencies to investigators via electronic submission system clarification request.
  • When conducting prereview for assigned submissions:
  • Conduct regular follow up with PIs on all outstanding issues resulting from pre review correspondence
  • Work with researchers to revise submissions and prepare for final board review
  • Evaluates all Full Board ongoing submission materials to determine consistency with IRB requirements for approval, including all NYUSoM Policies, applicable federal, state and local law and Good Clinical Practices
  • Assigns reviewers for submissions reviewed, assignments must be made consistent with reviewers medical and scientific expertise where appropriate.
  • Maintains rosters for each board, and updates OHRP and FDA consistent with regulatory requirements of each agency.
  • Attends weekly board premeeting briefing and performs prereview specialist responsibilities
  • Works with the Full Board Post-Review Specialist in generating minutes for all Board meetings
  • Provides vacation and sick leave coverage for the Full Board Post-Review Senior. Specialist as needed
  • Attends debriefings as needed following board meetings to verify understanding of the determinations to be used to when covering the creation of minutes
  • Provides guidance and assistance to the research staff to educate and assist them in IRB submission activities
  • Ensures all decisions for submissions are relayed to PI through official IRB correspondence in electronic system and ensures any communications they have with research teams outside the system are recorded in an appropriate communication comments in IRB system
  • Provides support and assistance for any additional work as required by the SSM
  • Maintains Board Member evaluation process and all Board member requirements including collecting and storing CVs, tracking ongoing educational completion and attendance reports for annual stipends.
  • Facilitates and conducts new Board member onboarding activities following Work Instructions
  • Assists the SSM with special projects, policy formulation and protocol related issues
  • Develops PowerPoint presentations and participates in education and training sessions for the research community. This will require working with the IRB Education Manager

Additional Position Specific Responsibilities:


Liaise with affiliate research committees and administrative staff (e.g., CRSU, PRMC) to identify additional deficiencies and/or to determine that requisite approvals have been received.

Conduct quality assurance reviews using weekly database reports and/or searches to determine status of workload. Provide organized and planned educational sessions for research community.


Minimum Qualifications:


Preferred Qualifications:


Certified IRB Professional (CIP) or Certified IRB Manager (CIM) certification preferred OR to be obtained within 1 year of employment.

Masters Degree.

NYU Grossman School of Medicine provides its staff with far more than just a place to work.

Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.

NYU Langone Health provides a salary range to comply with the New York state Law on
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