Compliance Monitoring Specialist – Neurology
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Job Description
Remote compliance specialist monitoring Johns Hopkins neurology clinical-trial data. Reviewing records, supporting audits, tracking findings, and improving research compliance.
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 summaries of compliance review results
- Meet with principal investigators and data support staff to review compliance results
- Follow up on compliance findings and non-compliance issues
- Maintain scheduling and review information in OnCore
- Help study staff prepare for external audits
- Participate in unscheduled internal reviews and compliance monitoring reviews at affiliate institutions as needed
- Generate queries, monitoring summary reports, and compliance findings
- Research regulations and review protocols and case report templates
- Assist staff in developing corrective actions for compliance observations
- Assist in training new research staff and make presentations as needed
- Participate on subcommittees by reviewing and coding new studies
- Prepare committee study reviews
- Attend monthly meetings
- Assist with development and maintenance of SOPs for the research manual website
- Perform periodic compliance reviews
- Conduct routine remote and on-site monitoring visits using established tools and checklists
- Assist with preparing studies and documentation for internal and external audits and inspections
- Track and follow up on findings to support timely resolution and compliance improvement
- Maintain monitoring trackers, logs, and reporting tools for audit readiness
- Perform other duties as assigned
Requirements:
- 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 preferred
- Certification in human subjects research preferred
- Intermediate clinical documentation review
- Intermediate data analysis
- Intermediate documentation
- Intermediate project management
- Intermediate regulatory compliance
- Intermediate SOP development
- Intermediate training and development
- Successful candidate subject to a pre-employment background check
- Applicants completing their final academic semester/quarter may be considered eligible for employment
- Must comply with applicable Johns Hopkins vaccination requirements
Benefits:
- Total rewards package supporting employees' health, life, career and retirement
- Seasonal flu vaccine required by Johns Hopkins University, with religious or medical exceptions
- Required vaccinations for applicable clinical, laboratory, research-subject, or community-contact positions provided at no cost through Occupational Health
- Remote work arrangement
- Pre-employment accommodation support
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