Senior Specialist-Institutional Review Board Operations

Job Responsibilities:

• Evaluates all Full Board initial submission materials to determine consistency with IRB requirements for approval, including all NYU Langone Health Policies, applicable federal, state, and local law, and Good Clinical Practices
• Attends weekly board pre-meeting briefing and performs post-review specialist responsibilities
• Attends weekly board meeting and performs post-review specialist responsibilities including guiding IRB members to make the necessary required findings
• Generates approval letters and issues letter for all new submissions
• Attends debriefings (and leads as requested by AD) following board meetings to ensure understanding of the determinations, which will be used to generate minutes and letters
• Writes all approval and modification letters
• Develops elements of the meeting agenda and assigns reviewers when required
• Provides guidance, education, and assistance in IRB submission activities to research staff
• Ensures communications with research teams are recorded in an appropriate communication filing system
• Ensures all decisions for new study submissions are relayed to Principal Investigator (PI) through official IRB correspondence in electronic system
• Serves as a designated reviewer and performs all final determinations on the new submissions of expedited and exempt categories
• Analyzes submission documents (protocol, consent and other relevant documents) for completeness consistent with board decision and communicates all identified deficiencies to investigators via the electronic submission systems clarification request
• When acting as a pre-reviewer for initial submissions:
  Assesses whether the submission requires an IND/IDE and guides the PI with the application process if necessary
  Determines, write, and relays deficiencies in IRB submissions clearly and concisely to PIs through official pre-review correspondence via email
  Conducts regular follow up with PIs on all outstanding issues resulting from pre-review correspondence
  Works with researchers to revise submissions and prepares for final board review or designated review
• Provides support and assistance for any additional work as required by the AD
• Assists the AD with special projects, policy formulation, and protocol related issues
• Obtains CIP certification or equivalent within 1 year of employment
• Write and relay clear and concise response review issues to PI through Research Navigator
• Develop PowerPoint presentations and participates in education and training sessions for the research community alongside IRB Education Manager
• Provides day-to-day operations support for reliance coordinators as required, including:
  Approving the use of NYUGSOM IRB as a Single IRB (sIRB)
  Approving the use external IRBs based on institutional policies
  Processing reliance agreements
  Guiding investigators in complying with institutional requirements applicable to sIRB and external IRB processes
  Communicating with relying institution teams to facilitate IRB approvals

Additional Position Specific Responsibilities:

Additional Position Responsibilities:
Ensures all submissions are entered in electronic database system on a daily basis and all communications with researchers are logged in appropriate communication filing system
Liaises with affiliate research committees and administrative staff (e.g., CTSI, PRMC) to identify additional deficiencies and/or to determine that requisite approvals have been received
Conducts quality assurance reviews using weekly database reports and/or searches to determine status of workload
Provides organized and planned educational sessions for research community