IRB Compliance Monitoring Specialist; Office of Human Subjects Research

IRB Compliance Monitoring Specialist (Office of Human Subjects Research)

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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.

• Schedule and conduct monitoring reviews for IRB approved studies
• Conduct pre and post enrollment research record reviews for IND/IDE sponsor investigators
• 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

• 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