Scientific Research Manager (IRB)

Job Responsibilities:

• Oversee the day-to-day operations of all full board submissions 
• Conduct scientific, ethical and regulatory oversight of full board submissions to:  
• Ensure completeness and accuracy of information and required documentation by using the appropriate review checklists. 
• Ensure the protocol and other relevant documents are in compliance with NYU SoM Policies & procedures, federal, state and local law, as well as good clinical practices. 
• Determine whether the submission requires an IND/IDE 
• Perform final review and make final determination of a submission `readiness for all new protocols, continuations, amendments before board assignment is made  
• Review of all initial full board agenda items in preparation for meetings of Boards A, B, C, D, F, and G 
• Make final determination on all submissions that qualify for expedited review and liaise with appropriate HRP Staff to ensure appropriate review 
• Conduct comprehensive pre-review of reportable events and make determinations based on the NYU SOM RNI policy 
• Lead prebriefings with IRB staff and IRB Chair to ensure any outstanding deficiencies are discussed and addressed, and any findings that need to be made at the IRB meeting are communicated to the Chair. 
• Lead debriefings following each board meetings to verify staffs understanding of the boards determinations to be used to generate minutes and letters 
• Attend Board E compliance meetings, take meeting minutes, and manages post-review responsibilities.  
• Create and send audit board determination letters, including findings of non-compliance, serious or continuing non-compliance, and study suspension 
• Created any board correspondence regarding non-compliance in a timely manner and works with the Senior Director, HRP, Office of General Counsel and NYC Health + Hospitals (as applicable) to ensure accuracy of information before letters are finalized.  
• Manages dissemination of the board letters regarding non-compliance that require reporting to Federal Agencies and ensures timely reporting to Federal to the Principal Investigator, Institutional Leadership and the Federal government ,OHRP, FDA and other agencies as needed. 
• Maintain a detailed log of all instances of non-compliance, UAPs, federal correspondence, allegations of non-compliance, and audit / RNI action items. 
• Conduct regular follow up with PIs on all outstanding issues resulting audit board determinations 
• Oversee responses to deferrals and assess readiness for re-review by the IRB 
• Write and relay concise response review issues to PI through Research Navigator  
• Ensure all communications with research teams are recorded in Research Navigator 
• Manage all aspects of IRB meetings, including attending each meeting, meeting minutes, and post-review decisions to final outcome of all agenda items.  
• Manage compliance related board determination letters, including findings of non-compliance, serious or continuing non-compliance, and study suspension 
• Maintain the non-compliance log and track all instances of non-compliance, UAPs, federal correspondence, allegations of non-compliance, and audit / RNI action items to completeion . 
• Manage assignment of primary reviewers for full board protocol review while ensuring that protocols are distributed in an equitable and specialty-specific manner. Verify the absence of reviewers conflicts 
• Ensure all controverted issues and their resolution and Board determinations are recorded in IRB meeting minutes 
• Oversee debriefings following Board meetings to verify understanding of the determinations 
• Generate and issue all board determination (deferral, modifications required, and approval) letters for initial submissions, documenting all IRB determinations 
• Review all board determination (deferral, modifications required, and approval) letters for modification and continuation submissions prior to release by Senior Analyst 
• Attend all board meetings as a voting member, and work with IRB Chair to manage each Board meeting to ensure regulatory findings are made and appropriate for each full board submission. 
• Lead prebriefings with IRB staff and IRB Chair to ensure any outstanding deficiencies are discussed and addressed, and any findings that need to be made at the IRB meeting are communicated to the Chair. 
• Develop, generate and distribute meeting minutes to the Associate Director for pre-review, prior to distribution to the Chair, Sr. HRP Director, and appropriate Board for review and approval 
• Oversee outstanding issues resulting from Deferrals of new studies and follow up with PI to ensure completion. 
• Oversee elements of the meeting agenda and assign reviewers when required  
• Provide guidance and training to the Full Board IRB staff to educate and assist them in IRB submission activities  
• Performs designated review for submissions that qualify for review under expedited procedures 
• Performs review and designated review of responses to conditional approvals.  
• Performs Full Board new study reviews from submission to approval when required 
• Work with Associate Director on regular Quality Control reviews, twice a year  
• Develop power point presentations and participate in education and training sessions for research community, IRB staff, and IRB members. This will require working with IRB Education Manager  
• Provide coverage of aspects of other managers responsibilities when the manager is not available; agenda, review of letters, interact and direct staff and communicate with research teams to resolve issues related to IRB determinations   
• Provide support and assistance for any additional work as required by the Associate Director