Compliance Monitoring Specialist (Oncology)

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.

• Bachelor's Degree.
• Three years of related experience with clinical trials/medical research.
• 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

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

Classified Title: Compliance Monitoring Specialist
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($65,400 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8a - 4:30p
FLSA Status:Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Clinical Research Office
Personnel area: School of Medicine