Compliance Monitoring Specialist – Neurology

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Coordinate compliance monitoring visits with research study personnel.

• Create protocol-specific documentation.

• Examine research and medical records for adherence to clinical protocols.

• Draft written summaries detailing compliance review findings.

• Collaborate with principal investigators and data support personnel to discuss compliance findings.

• Address compliance issues and follow up on non-compliance matters.

• Keep scheduling and review data updated in OnCore.

• Assist study staff in preparation for external audits.

• Engage in unplanned internal reviews and compliance monitoring evaluations at affiliated institutions as necessary.

• Produce queries, monitoring summary reports, and compliance observations.

• Investigate regulations and assess protocols and case report templates.

• Support staff in formulating corrective measures for compliance issues.

• Aid in training new research personnel and deliver presentations as required.

• Contribute to subcommittees by reviewing and coding new studies.

• Compile committee study assessments.

• Attend monthly meetings.

• Help in the creation and upkeep of SOPs for the research manual website.

• Conduct periodic compliance assessments.

• Execute routine remote and on-site monitoring visits using standardized tools and checklists.

• Assist in the preparation of studies and documentation for internal and external audits and inspections.

• Monitor and follow up on findings to ensure prompt resolution and enhancement of compliance.

• Maintain monitoring trackers, logs, and reporting tools for audit preparedness.

• Perform other assigned responsibilities.

⛳️ Requirements

• Bachelor’s Degree.

• Three years of relevant experience in clinical trials or medical research.

• Eligibility for certification by a professional body in human subjects research.

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

• Preferred Bachelor’s Degree in Life Sciences, Health Care, or a related discipline.

• Preferred certification in human subjects research.

• Intermediate skills in clinical documentation review.

• Intermediate data analysis capabilities.

• Intermediate documentation proficiency.

• Intermediate project management skills.

• Intermediate understanding of regulatory compliance.

• Intermediate SOP development expertise.

• Intermediate training and development experience.

• Successful candidates will be subject to a pre-employment background screening.

• Applicants in their final academic semester or quarter may be eligible for employment consideration.

• Compliance with applicable Johns Hopkins vaccination requirements is mandatory.

🏝️ Benefits

• Comprehensive rewards package that promotes employees' health, life, career, and retirement.

• Seasonal flu vaccination is mandatory per Johns Hopkins University, with accommodations for religious or medical reasons.

• Required vaccinations for relevant clinical, laboratory, research-subject, or community-contact roles are provided at no charge through Occupational Health.

• Flexible remote work options.

• Support for pre-employment accommodations.