Senior IRB Specialist

Remote, USA Full-time
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 Apply tot his job
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