IRB Generalist - Richmond, United States - Commonwealth of Virginia

Description

We are looking for an IRB Operational Manager at VCU

Job Description Summary and General Duties:

The IRB Generalist plays a vital role at Virginia Commonwealth University by facilitating the review and implementation of reliance agreements, individual investigator agreements, and ceding memos. Proficiency in platforms like Smart IRB and IRex is essential for streamlining the reliance process and ensuring compliance with institutional policies and federal regulations governing human participant research. Effective collaboration between research institutions is a key aspect of this role.

• Conduct comprehensive pre-review and post-review analyses of IRB submissions
• Identify and address missing information, coordinating with investigators for remediation
• Verify ancillary committee reviews and facilitate external IRB review
• Meticulously maintain records of IRB reliance relationships and approved studies by external IRBs
• Serve as a liaison between external IRBs, the Office of Research and Sponsored Programs, and VCU study teams
• Provide guidance to researchers and manage the IRB Reliance Program

Key Responsibilities:

• Reliance Agreement Review: Ensure alignment with institutional policies and regulatory requirements
• Smart IRB and IRex Management: Utilize platforms for streamlined reliance processes
• Compliance Assurance: Verify compliance with policies and federal regulations
• Communication and Collaboration: Act as a liaison between stakeholders and facilitate effective communication
• Conduct Single Reviewer and Administrative Reviews: Essential tasks for efficient research protocol oversight

Expanded Overview:

• Initial Protocol Screening: Evaluate research protocols for review pathway determination
• Single Reviewer Review: Assess protocol documents for compliance and feasibility
• Administrative Review: Verify completeness and accuracy of protocol submissions
• Communication and Coordination: Coordinate with investigators and IRB staff throughout the process
• Regulatory Compliance: Ensure adherence to federal regulations and ethical standards
• Documentation and Record Keeping: Maintain meticulous records for auditing purposes
• Continuous Improvement: Identify and implement process enhancements

Minimum Hiring Standards:

Bachelor's degree in a related field, 2 years of IRB analyst experience, and eligibility for Certified IRB Professional (CIP) certification.

Preferred Hiring Standards:

Master's degree in a related field, 5 years of IRB analyst experience, Certified IRB Professional (CIP), and expertise in human participant research.

Additional Employment Information

Full-time university staff enjoy our comprehensive benefits package, including health, vision, dental coverage, life insurance, retirement planning, paid-time off, and more.

Join us at VCU, where we embody the UNCOMMON and UNSTOPPABLE, driving innovation and success in a diverse and supportive environment.