Regulatory Specialist - IRB Analyst
Our client, a leading Child Health Advocacy organization in the Greater Washington, DC metro area, has an immediate need for both a tenured Regulatory Compliance Specialist and SR Regulatory Affair Specialist.
As Regulatory Specialist, you will support the Institutional Review Board: conduct human subject protection protocol re-views, manage Board meetings, consult with investigators and research staff, serve as Board liaison, and contribute to procedure manuals, office management and training.
• Manage multiple priorities and a high-volume workload: coordinates, monitor, and provide regulatory compliance assistance to Institutional Review Board (IRB) and or IRB Chair
• Analyze protocol submissions for completeness, accuracy; and internal consistency of the application materials
• Work directly with investigators to improve the quality of application materials for IRB review
• Make recommendation for the appropriate level of IRB review in accordance with federal and institutional codes, rules, and regulations governing biomedical research
• Provide professional service to the Chair, Committee, and clinical investigators
• Generate regulatory compliance pre-review; develop meeting agenda and supplemental materials and meeting packets
• Compose summaries of the Committee’s technical deliberations and generate minutes; generate correspondence from IRB meeting for review by Manager and IRB Chair; generate all board related correspondence to PI and verifying the accuracy and timeliness
• Bachelor’s degree or equivalent work experience in IRB office. Master’s degree preferred
• Minimum of 3 – 5 years work experience in IRB/Research administration. Regulatory experience required
• CIP (Certified IRB Professional) preferred. Required for SR position
• Demonstrated knowledge of scientific and medical terminology
• Demonstrated ability to analyze and comprehend Research protocols
• Thorough knowledge of federal and state laws, regulation, institutional policies and guidelines to protect human subjects
• Demonstrated ability to make technical presentations to expert audience and handle confidential information
Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!
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