Program Manager, IRB Reliance Agreements and External Review

Nso 1001 University Place Evanstonmid

OperationsProject Manager

1 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

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).

Requirements Summary

Conducts non-committee reviews, serves as an alternate member of the IRB, works collaboratively with IRB administrative staff, and contributes to IRB Committee meetings.

Technical Tools

OperationsProject Manager

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

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

Responsibilities

~2 min read

→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

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.

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).

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 & 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 We Offer

~2 min read

✓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

Location & Eligibility

Where is the job

Nso 1001 University Place Evanston

On-site at the office

Who can apply

Same as job location

About this job

Pay per year: ≈ $82,035–$127,150 a year; 24% below the $137,280 median for Project Manager jobs on Jobera (2,738 salaries).
Posted: Today
Employer: has 1,518 open jobs on Jobera.