Job Details

Compliance Monitoring Specialist

The Department of Neurology is seeking a Compliance Monitoring Specialist for the BIOS division in the School of Medicine. This position ensures quality, accuracy, and integrity of multi-center clinical trial data through risk-based remote monitoring and compliance oversight, supporting BIOS CTCC's mission to advance neurological research. The Compliance Monitoring Specialist is responsible for conducting compliance monitoring reviews of clinical research trials in keeping with established policies and procedures.

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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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