Program Manager, IRB Reliance Agreements and External Review

Hourly Pay Range:

Position Highlights:

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

A Brief Overview:
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.

What you will do:

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 practices to ensure satisfactory compliance.
• Policy & SOP Creation: Assists Endeavor leadership in the creation and maintenance of internal policies and Standard Operating Procedures (SOPs).
• Leadership Collaboration: Works with the Director of the Office of Research Integrity to apply policies, procedures, and regulations related to the conduct of research determination of human subjects. Participates in HRPP evaluation, strategic planning and formulation of goals and objectives.
• Organizational Alignment: Works with affiliated Endeavor organizations in their conduct of research to ensure regulatory compliance, as well as adhering to Endeavor and unit-level policies to safeguard assets

Training, Initiatives & Institutional Growth

• Training & Education: Ensures adequate Human Research Protection training and education necessary for the Reliance Agreement process to IRB staff, and the research community has been completed or developed, and actively participates in administering training.
• System-Wide Initiatives: Leads and participates in system-wide research institute initiatives that promote consistency, alignment, and "one research institute," alongside operational management of human subjects research protection.
• Other duties as assigned

What you will need:

• Education:Bachelors Degree Required, Masters Degree Preferred
• Experience:Minimum of 5 years’ experience in Research Compliance and Management of IRB Program Activities in a research or healthcare setting .Huron eIRB platform
• Skills:Ability to demonstrate understanding of the principles of human research protection standards
• Comprehensive knowledge of regulatory information regarding the use of human participation in research
• Occasional local travel may be necessary
• This position is a hybrid work role - a combination of onsite work and telecommuting - based on business and operational needs.
• Strong interpersonal and communication skills with the ability to work collaboratively and effectively with a wide range of stakeholders
• Strong understanding of federal and state laws and regulations governing human subjects research
• Ability to analyze complex scientific and ethical issues, creativity in finding solutions and discretion in handling confidential and sensitive matters
• Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching.
• Demonstrated understanding of the principles of human research protection standards
• Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
• In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
• Demonstrated strong verbal and written communication skills. Knowledge of human subjects and, federal and state policies and procedures.
• Knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management

Benefits (For full time or part time positions):

• Eligibility for our Annual Incentive Plan, which offers the potential to earn a certain percentage amount of your base salary based on organizational performance. (For AIP eligible positions)
• Premium pay such as shift, on call, holiday and more based on an employee’s job (For eligible positions)
• Incentive pay for select positions
• Opportunity for annual increases based on performance
• Career Pathways to Promote Professional Growth and Development
• Various Medical, Dental, Pet and Vision options
• Tuition Reimbursement
• Free Parking
• Wellness Program Savings Plan
• Health Savings Account Options
• Retirement Options with Company Match
• Paid Time Off and Holiday Pay
• Community Involvement Opportunities

Endeavor Health is a fully integrated healthcare delivery system committed to providing access to quality, vibrant, community-connected care, serving an area of more than 4.2 million residents across six northeast Illinois counties. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence. For more information, visitwww.endeavorhealth.org.  

When you work for Endeavor Health, you will be part of an organization that encourages its employees to achieve career goals and maximize their professional potential.

Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to “help everyone in our communities be their best”. 

Endeavor Health is committed to working with and providing reasonable accommodation to individuals with disabilities. Please refer to the main career page for more information.

At Endeavor Health, we are united by a shared commitment to working together to create a culture of connection and belonging—each of us bringing different skills and experiences as we deliver safe, seamless, and personal care. Every person, every time. We are committed to fostering an environment where all team members can be their best, learn, and pursue excellence together.

EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.