Senior IRB Specialist
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. • Assess research protocols for completeness and accuracy in an efficient manner.
• Train new IRB members on the CU electronic review system (Rascal). • Organize convened IRB meetings and manage all related activities. • Provide regulatory expertise during IRB meetings and ensure compliance of meeting minutes. • 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. • Four years of experience, including at least two years of direct IRB experience.
• Up-to-date knowledge of state and federal regulations governing human subject research. • Strong organizational and time management skills. • Excellent interpersonal and written communication skills. • Ability to work collaboratively and independently in a high-intensity environment.
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 staff.
Benefits • Health insurance • Dental insurance • Retirement savings plan (401k) • Paid holidays • Paid time off (PTO) • Flexible scheduling
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• 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. • Assess research protocols for completeness and accuracy in an efficient manner.
• Train new IRB members on the CU electronic review system (Rascal). • Organize convened IRB meetings and manage all related activities. • Provide regulatory expertise during IRB meetings and ensure compliance of meeting minutes. • 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. • Four years of experience, including at least two years of direct IRB experience.
• Up-to-date knowledge of state and federal regulations governing human subject research. • Strong organizational and time management skills. • Excellent interpersonal and written communication skills. • Ability to work collaboratively and independently in a high-intensity environment.
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 staff.
Benefits • Health insurance • Dental insurance • Retirement savings plan (401k) • Paid holidays • Paid time off (PTO) • Flexible scheduling
Apply Now
Apply Now