IRB Compliance Monitoring Specialist; Office of Human Subjects Research

Benefits

Qualifications

• •Bachelor’s Degree
• •Three years of related clinical/medical research experience
• •Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula
• •IRB Compliance Monitoring Specialist
• •1 more items(s)

Responsibilities

• •IRB Compliance Monitoring Specialist
• •who will be part of a team that supports the JHM Institutional Review Boards (IRBs)
• •This role conducts internal compliance monitoring of IRB-approved human subject research and prepares summary reports
• •Schedule and conduct monitoring reviews for IRB approved studies
• •Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to review the available FDA required documentation for completeness and accuracy
• •Familiarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trial
• •Discuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of records
• •Review regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trial
• •During the review, prepare a written report of findings and observations
• •Discuss with principal investigators and study team members the regulatory and participant review findings, to reconcile compliance issues and provide corrective action recommendations based on regulatory requirements and best-practices
• •Provide support and resources based on regulatory requirements and best practices
• •Finalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review Board
• •Participate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance compliance
• •Conduct customized research compliance in-service training sessions at the request of JHM departments or divisions
• •Serve as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulations
• •Provide practical recommendations to implement strategies to increase regulatory and subject compliance
• •Ability to establish priorities, work independently, and proceed with objectives in a fast-paced, online environment
• •Other duties as assigned
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