Compliance Monitoring Specialist (Neurology)

Specific Duties & Responsibilities

• Schedule compliance monitoring visits with research study staff.
• Develop protocol specific forms.
• Review research and medical records against clinical protocols for compliance.
• Prepare written summary of compliance review results.
• Meet with principal investigators and data support staff to review compliance results.
• Follow-up on results, as necessary.
• Maintain scheduling and review information in OnCore for all protocol reviews.
• Help study staff to prepare for external audits.
• Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions as needed.
• Schedule compliance monitoring visits with research study staff to monitor data integrity studies.
• Generate queries and conduct follow-up for non-compliance issues.
• Generate monitoring summary reports and communicate these findings.
• Provide support for monitored trials in the form of research into regulations and review of protocols and Case report templates for protocol staff.
• Assist staff in developing corrective actions for compliance review observations when appropriate.
• Assist in training new research staff regarding research compliance; may make presentations to support this effort.
• Participate on subcommittees by reviewing new studies for quality assurance and general content, and coding new studies.
• Prepare reviews of studies by various committees.
• Attend and participate in monthly meetings.
• Assist in the development and maintenance of SOPs for the research manual on assigned areas website as needed.
• Perform periodic compliance reviews.
• Other duties as assigned.

In addition to the duties above

• Conducts routine monitoring visits (remote and on-site) using established tools and checklists and documents findings.
• Assists with preparing studies and documentation for internal and external audits and inspections.
• Tracks and follows up on identified findings to support timely resolution and compliance improvement.
• Supports maintenance of monitoring trackers, logs, and reporting tools to ensure audit readiness.

• Bachelor's Degree.

• Three years of related experience with clinical trials/medical research.

• Eligible for certification by a professional organization in human subjects research.

• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Bachelor's Degree in Life Sciences, Health Care or a related field.
• Certification in human subjects research.

Technical Skills & Expected Level of Proficiency

• Clinical Documentation Review - Intermediate
• Data Analysis - Intermediate
• Documentation - Intermediate
• Project Management - Intermediate
• Regulatory Compliance - Intermediate
• SOP Development - Intermediate
• Training and Development - Intermediate

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title: Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $49,200 - $86,200 Annually ($55,800 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
FLSA Status:Exempt
Location: Remote
Department name: SOM Neuro BIOS
Personnel area: School of Medicine