About the position
Responsibilities
• Manage a large volume of research protocols and related submissions from assignment through IRB approval.
• Ensure compliance of research protocols with CU IRB standard operating procedures and applicable regulations.
• Lead the IRB team to meet HRPO's expectations for quality and productivity.
• Supervise and train direct reports to provide administrative and regulatory support to the IRB.
• Evaluate research protocols for completeness and accuracy according to regulations.
• Train new IRB members on the CU electronic review system (Rascal).
• Organize convened IRB meetings and manage pre-meeting, meeting, and post-meeting activities.
• Provide regulatory expertise during IRB meetings and ensure compliance of meeting minutes with federal standards.
• Conduct quality control functions for HRPO operations.
• Serve as a voting member of the IRB and assist in the evaluation of IRB Chairs and members.
Requirements
• Bachelor's Degree or equivalent in education and experience plus four years of experience.
• Up-to-date knowledge of state and federal regulations related to human subject protection.
• Strong organizational and time management skills to support a large volume of submissions.
• Strong decision-making skills and ability to assess multiple issues analytically.
• Excellent interpersonal and written communication skills.
• Ability to work collaboratively in a positive manner.
• Solid computer skills and strong competency in Microsoft Office products.
Nice-to-haves
• Experience with biomedical, behavioral, and social sciences human research.
• Knowledge of international ethical codes and regulations governing human subjects research.
• Certification as an IRB professional.
• Experience supervising IRB specialists.
Benefits
• Health insurance
• Dental insurance
• 401k retirement plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities
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