IRB Compliance Monitoring Specialist (Office of Human Subjects Research)

We are seeking anIRB Compliance Monitoring Specialistwho 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 & ResponsibilitiesSchedule and conduct monitoring reviews for IRB approved studiesConduct pre and post enrollment research record reviews for IND/IDE sponsor investigators to review the available FDA required documentation for completeness and accuracyFamiliarize sponsor investigators with applicable FDA regulations and responsibilities relative to their role and proper conduct of the trialDiscuss and evaluate provisions for monitoring, investigative product accountability, study-team member supervision and training, and maintenance of recordsReview regulatory materials and research participant records to ensure compliance with the approved study protocol and the conduct of the clinical trialDuring the review, prepare a written report of findings and observationsDiscuss 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-practicesProvide support and resources based on regulatory requirements and best practicesFinalize and submit written reports of monitoring findings and recommendations for review by the Institutional Review BoardParticipate in Compliance Monitoring Program (CMP) educational activities to improve compliance and convey best-practices techniques to enhance complianceConduct customized research compliance in-service training sessions at the request of JHM departments or divisionsServe as a resource for inquiries from the JHU research community regarding institutional policies and FDA regulationsProvide practical recommendations to implement strategies to increase regulatory and subject complianceAbility to establish priorities, work independently, and proceed with objectives in a fast-paced, online environmentOther duties as assignedMinimum QualificationsBachelor'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 SpecialistRole/Level/Range: ACRP/04/MCStarting Salary Range: $48,000 - $84,100 Annually ($50,000 targeted; Commensurate w/exp.)Employee group: Full TimeSchedule: Monday - Friday 8:30am - 5:00pmFLSA Status:ExemptLocation: RemoteDepartment name: SOM Admin Clinical Invest Human SubjectsPersonnel area: School of MedicineJ-18808-Ljbffr Johns Hopkins University