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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 for clinical trials, ensuring adherence to ICH GCP and FDA guidelines while maintaining data integrity and quality. Proficient in training staff and developing monitoring plans to support regulatory compliance and quality assurance.
Highest-signal resume keywords
Compliance MonitoringICH GCP KnowledgeRegulatory ComplianceClinical Trial AuditingData Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Documentation ReviewData AnalysisDocumentationProject ManagementRegulatory ComplianceSOP DevelopmentTraining and Development
Soft Skills
Attention to DetailCollaborationCommunication
Tools & Technologies
Electronic Data Capturing SystemsREDCapSharePointEIRB Systems
Certifications & Qualifications
Certification in Human Subjects ResearchCertified Clinical Research Associate (CCRA)
Industry Keywords
Clinical TrialsQuality AssuranceRisk-Based MonitoringTrial Master FileAdverse Events Reporting
About the role
Key responsibilities & impact- Lead compliance monitoring of predominantly large, multi-centered clinical trials for the BIOS Clinical Trials Coordinating Center
- Ensure quality, accuracy, and integrity of clinical trial data throughout multiple trial lifecycles using a risk-based remote monitoring approach
- Collaborate with clinical trial teams across the country
- Monitor trial cycle metrics, protocol fidelity, and local, institutional, and federally required regulatory compliance
- Track regulatory submissions, recruitment, CRF completion, and data query resolution
- Review new studies for quality assurance and general content as part of risk assessments
- Develop standard, protocol-specific, and trial-specific forms and monitoring plans
- Collect and maintain essential documents and deliver them to the Trial Master File
- Train new research staff on research compliance and conduct presentations
- Generate queries, follow up on non-compliance, prepare monitoring summary reports, and communicate findings to investigators, research staff, and the Safety Monitoring Committee
- Verify informed consent, source documents, trial records, and CRFs for accuracy, completeness, legibility, and consistency
- Communicate protocol, SOP, GCP, and regulatory deviations and take appropriate corrective action
- Determine whether adverse events are reported within required timelines
- Schedule compliance monitoring visits and evaluate site practices and GCP compliance
- Escalate quality issues and assist with corrective actions
- Help study staff prepare for external audits and participate in internal reviews at affiliate institutions as needed
- Educate investigators, clinical sites, and coordinators on remote monitoring and remote data entry
- Travel minimally for monitoring visits
Requirements
What you’ll need- Bachelor’s Degree
- Five years of related experience with clinical trials/medical research
- Thorough knowledge of ICH GCP and FDA guidelines
- Experience using electronic data capturing systems
- Strong attention to detail in clinical trial data, source document, and regulatory compliance review
- Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, subject to the JHU equivalency formula
- Preferred: Bachelor's Degree in Life Sciences, Health Care or related field
- Preferred: Certification in human subjects research
- Preferred: Certified Clinical Research Associate (CCRA) credentialing
- Preferred: Experience with quality assurance or clinical trial auditing/monitoring and/or good clinical practice
- Preferred: Experience with REDCap, SharePoint, and eIRB systems
- Clinical Documentation Review - Intermediate
- Data Analysis - Intermediate
- Documentation - Intermediate
- Project Management - Intermediate
- Regulatory Compliance - Intermediate
- SOP Development - Intermediate
- Training and Development - Intermediate
Benefits
Comp & perks- Total rewards package supporting health, life, career, and retirement
- Seasonal flu vaccine required by Johns Hopkins University, with religious or medical exceptions
- Required vaccinations for applicable positions provided at no cost through Occupational Health
- Pre-employment accommodations available
- Equal opportunity employment
- Background-check process considers justice-involved backgrounds individually