Program Manager, IRB Reliance Agreements and External Review

Endeavor Health•Evanston, IL

3d•$39 - $61•Hybrid

About The Position

The Office of Research Integrity within the Endeavor Health Research Institute oversees and manages the organization’s research administrative compliance committees and ensures adherence to applicable policies, standards, and external regulations. This position manages the external Institutional Review Board (IRB) process and serves as a liaison between research users and commercial IRBs. Reporting to the Director, Research Integrity, the Research Compliance Program Manager manages the external reliance agreement portfolio for human-subject research, particularly clinical research trials. The role manages intake and local review of submitted protocols before they are sent to an external committee. It ensures accurate data entry in the IRB management system and manages communication with the external IRB and investigators from study inception through closeout. The position is hybrid, combining onsite work and telecommuting based on business and operational needs, and may require occasional local travel.

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 regulations concerning human participation in research.
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-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.

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 assist research users in navigating it.
Serve as an expert liaison between investigators and external IRBs, educating parties on relevant and emerging regulations and related risk-management issues.
Communicate with federal regulatory agencies, 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 and pre-submission audits of submissions to external IRBs, ensuring legal, regulatory, quality, and documentation requirements are met.
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 regulations, policies, and review criteria.
Develop workflows and checklists for administrative review and maintain related databases, electronic audit files, and metrics.
Administer and implement IRB policies and procedures related to external IRBs and human-subject research at Endeavor Health.
Monitor legislation and regulatory changes affecting research compliance and recommend administrative policy or procedure changes as appropriate.
Apply federal, state, and local regulations, policies, and practices to support compliance.
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 involving human-subject research.
Participate in Human Research Protection Program evaluation, strategic planning, and the formulation 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 for IRB staff and the research community is completed or developed, and participate in administering training.
Lead and participate in system-wide research institute initiatives that promote consistency and alignment in human-subject research protection.
Perform other duties as assigned.

Benefits

Eligibility for an Annual Incentive Plan, offering the potential to earn a percentage of base salary based on organizational performance, for eligible positions.
Premium pay such as shift, on-call, and holiday pay, based on the job and eligibility.
Incentive pay for select positions.
Opportunity for annual performance-based increases.
Career pathways to promote professional growth and development.
Medical, dental, pet, and vision plan 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.