IRB Compliance Monitoring Specialist (Office of Human Subjects Research)

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.

• 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