Head of Programme Management

Hourly Pay Range:
$39.44 - $61.13 - The hourly pay rate offered is determined by a candidate's expertise and years of experience, among other factors.

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.
What you will do: External IRB Management & Liaison Operation
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.
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.
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
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.
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.
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).
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.
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.
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.
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
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.
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.
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.
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. (Premium pay such as shift, on call, holiday and more based on an employee’s job (For eligible positions)
Opportunity for annual increases based on performance
Various Medical, Dental, Pet and Vision options
Tuition Reimbursement
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. Please explore our website () 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. 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. EOE: Race/Color/Sex/Sexual Orientation/ Gender Identity/Religion/National Origin/Disability/Vets, VEVRRA Federal Contractor.