IRB Compliance Monitoring Specialist (Office of Human Subjects Research)

We are seeking an 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. Specific Duties & Responsibilities • 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. Minimum 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. Classified Title: IRB Compliance Monitoring Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: $48,000 - $84,100 Annually ($50,000 targeted; Commensurate w/exp.) Employee group: Full Time Schedule: Monday - Friday 8:30am - 5:00pm FLSA Status: Exempt Location: Remote Department name: SOM Admin Clinical Invest Human Subjects Personnel area: School of Medicine Apply tot his job Apply To this Job