Program Manager, IRB Reliance Agreements and External Review

Endeavor Health•Evanston, IL

2d•Hybrid

About The Position

The Office of Research Integrity within the Endeavor Health Research Institute oversees and manages research administrative compliance committees and ensures adherence to applicable policies, standards, and external regulations. The Program Manager manages the external IRB process and serves as a liaison between research users and commercial IRBs. Reporting to the Director, Research Integrity, this role manages the external reliance agreement portfolio for human-subject research, particularly clinical research trials. Responsibilities include intake and local review of protocols before submission to an external committee, accurate data entry in the IRB management system, and managing communications with external IRBs and investigators from study inception through closeout. This position is hybrid, combining onsite work and telecommuting based on business and operational needs. Occasional local travel may be necessary. The role is based in Evanston and works Monday through Friday; the posting notes flexible work schedules but does not specify particular hours.

Requirements

Bachelor's degree required.
At least 5 years of experience in research compliance and management of IRB program activities in a research or healthcare setting.
Ability to demonstrate understanding of human research protection principles and standards.
Comprehensive knowledge of regulatory information concerning human participation in research.
Strong interpersonal and communication skills and ability to collaborate effectively with a wide range of stakeholders.
Strong understanding of federal and state laws and regulations governing human-subject research.
Ability to analyze complex scientific and ethical issues, find creative solutions, and use discretion when handling confidential and sensitive matters.
Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
In-depth understanding of operational requirements for managing and implementing protocol processes.
Strong verbal and written communication skills.
Knowledge of human-subject research and applicable federal and state policies and procedures.
Occasional local travel may be necessary.

Nice To Haves

Master's degree preferred.
Experience with the Huron eIRB platform.

Responsibilities

Manage human-subject research activities involving external IRBs and the external reliance agreement portfolio.
Manage the external commercial IRB process and help research users navigate it.
Serve as an expert liaison between investigators and external IRBs, educating parties about relevant and emerging regulations and risk-management issues.
Communicate with federal regulatory agencies, including the FDA and OHRP, and with funding agencies and industry sponsors regarding IRB reliance issues.
Collaborate with internal units, including the Privacy Office and Corporate Compliance, to resolve compliance issues.
Coordinate with the Office for Clinical Research to ensure compliance with contractual terms in clinical trial agreements.
Conduct administrative reviews before external IRB submissions and work with IRB staff to ensure submissions meet legal, regulatory, quality, and documentation requirements.
Conduct non-committee reviews, serve as an alternate IRB member, collaborate with IRB administrative staff, and contribute to IRB committee meetings.
Review coordinator-prepared materials for adherence to federal regulations and advise IRB members on applicable regulations, policies, and review criteria.
Develop workflows and checklists for the administrative review process.
Maintain related databases, electronic audit files, and metrics, particularly those associated with external IRBs.
Administer and implement IRB policies and procedures related to external IRBs and human-subject research at Endeavor Health.
Monitor legislation and regulatory changes that may affect compliance and recommend updates to administrative policies and procedures.
Assist Endeavor leadership in creating and maintaining internal policies and standard operating procedures.
Work with the Director of the Office of Research Integrity on research policies, procedures, regulations, and determinations of human-subject research.
Participate in HRPP evaluation, strategic planning, and development of goals and objectives.
Work with affiliated Endeavor organizations to support regulatory compliance and adherence to organizational and unit-level policies.
Ensure Human Research Protection training and education related to the Reliance Agreement process is completed or developed, and participate in administering training.
Lead and participate in system-wide research institute initiatives promoting consistency and alignment.
Perform other duties as assigned.

Benefits

Eligibility for an Annual Incentive Plan, offering potential earnings based on organizational performance for eligible positions.
Premium pay, such as shift, on-call, and holiday pay, for eligible positions.
Incentive pay for select positions.
Opportunity for annual increases based on performance.
Career pathways to promote professional growth and development.
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.