Program Manager, IRB Reliance Agreements and External Review

• Position:
  Program Manager, IRB Reliance Agreements and External Review
• Location:
  
  Evanston
• Full Time
  
  Hours:
  
  Monday-Friday, [hours and flexible work schedules]

The Office of Research Integrity within the Endeavor Health Research Institute holds responsibility for oversight and management of Endeavor Health's research administrative compliance committees and ensures adherence with applicable policies, standards and external regulations. This position manages the external IRB (Institutional Review Board) process and serves as the liaison between the users and the commercial IRB. Reporting to the Director, Research Integrity, the Research Compliance Program Manager is responsible for the management of the external reliance agreement portfolio for human subject research, particularly around clinical research trials.

This role manages the intake and local review of submitted protocols before submitting protocols to the external committee. This individual ensures proper data entry within the IRB management system and manages all communication with the external IRB and the investigators from study inception through closeout.

• External IRB Management & Liaison Operation Strategic Oversight:
  Manages human subject's research activities specific to external IRBs (reporting directly to the Director of Research Integrity).
• Commercial IRB Support:
  Manages the external commercial IRB process and supports users by assisting in their navigation through this process.
• Expert Liaison:
  Serves as an expert liaison between the research investigator and external IRBs; educates parties on relevant and emerging regulations and related risk management issues.
• Communicates with federal regulatory agencies, such as the Food and Drug Administration, Office of Human Research Protections, and funding agencies such as the National Institutes of Health and Industry sponsors regarding IRB reliance issues.
• Cross-Functional Collaboration:
  
  Collaborates with internal units (e.g., Privacy Office, Corporate Compliance) to resolve compliance issues, and coordinates with the Office for Clinical Research to ensure compliance with contractual terms in clinical trials agreements.
• Submission Review, Quality Assurance & Administration Pre-submission Auditing:
  Conducts administrative reviews prior to submissions to external IRBs and interacts extensively with IRB staff members to ensure reports fulfill legal, regulatory, quality, and documentation requirements.
• Review Committee Participation:
  Conducts non-committee reviews, serves as an alternate member of the IRB, works collaboratively with IRB administrative staff, and contributes to IRB Committee meetings.
• Quality & Guidance:
  Responsible for advanced knowledge and higher-level review of coordinator preparation to ensure adherence to federal regulations, while advising IRB members on applicable regulations, policies, and review criteria.
• Process Optimization & Tracking:
  Develops workflows and checklists specific to the administrative review process. Maintains related databases, electronic audit files, and metrics (particularly those associated with external IRBs).
• Regulatory Compliance & Policy Development Administration & Implementation:
  Responsible for the administration and implementation of the Institutional Review Board (IRB) policies and procedures related to the conduct of human subject research at Endeavor Health for External IRB’s.
• Regulatory Tracking:
  Monitors new legislation or changes in regulations that might affect Endeavor's compliance in conducting research, recommending changes to administrative policies and procedures, as appropriate.
• Knowledge Application:
  Applies knowledge of federal, state, and local regulations, policies, and…