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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in compliance monitoring, clinical documentation review, and regulatory compliance within research studies. Proficient in developing protocols, training staff, and preparing for audits to ensure adherence to clinical protocols and standards.
Highest-signal resume keywords
Clinical Trials ExperienceRegulatory ComplianceSOP DevelopmentData AnalysisTraining and Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Documentation ReviewData AnalysisProject ManagementCompliance MonitoringProtocol DevelopmentCorrective Action DevelopmentMonitoring Summary ReportsAudit PreparationCompliance TrackingResearch Regulations
Soft Skills
CommunicationCollaborationProblem-SolvingAttention to DetailTraining
Tools & Technologies
OnCoreMonitoring ToolsChecklistsReporting Tools
Certifications & Qualifications
Certification in Human Subjects Research
Industry Keywords
Clinical ResearchMedical ResearchCompliance AuditsHuman Subjects ResearchLife Sciences
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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