JHU EEHPC — Джонс Хопкинс университетіндегі Энергия тиімділігі жоғары өнімді есептеу зертханасы, оны Тиноош Мохсенин басқарады. Зертхана киілетін және мобильді жүйелерге арналған ықшам әрі энергия тиімді есептеуге назар аудара отырып, медицина, денсаулық сақтау және киілетін технологияларды әзірлейді. Оның зерттеулері алгоритмдер, компьютер архитектурасы, аппараттық құралдар және жүйелерді біріктіру бағыттарын қамтиды; ақылды денсаулық мониторингі, робототехника және автономды навигация сияқты қолданбалар үшін жоғары өнімді есептеу мен жасанды интеллектіні ұштастырады. Зертхананың жұмысы озық есептеу зерттеулерін денсаулық сақтау, көлік және қоғамдық инфрақұрылым салаларындағы практикалық мәселелермен байланыстырады.
Senior Neurology Clinical Trial Compliance Monitoring Specialist (Remote, Maryland)
Lead risk-based remote compliance monitoring for multicenter neurology clinical trials. Safeguard GCP adherence, data integrity, regulatory accuracy, and site quality across study lifecycles.
Америка Құрама Штаттары
Мэриленд57 195 $ – 100 040 $ / жыл
ҚашықтанТолық жұмыс күніАға маманҚажетті Тіл: ағылшын тіліСәйкестікСипаттама
- Lead compliance monitoring for predominantly large, multicenter clinical trials managed by the BIOS Clinical Trials Coordinating Center
- Protect clinical trial data quality, accuracy, and integrity across study lifecycles through risk-based remote monitoring
- Partner with clinical trial teams nationwide
- Monitor trial metrics, protocol adherence, and required local, institutional, and federal regulatory compliance
- Track regulatory submissions, participant recruitment, CRF completion, and data-query resolution
- Assess new studies for quality assurance and content during risk assessments
- Create standard, protocol-specific, and trial-specific forms and monitoring plans
- Gather essential documents, maintain them, and submit them to the Trial Master File
- Train new research personnel in research compliance and deliver presentations
- Issue queries, follow up on noncompliance, prepare monitoring summaries, and communicate findings to investigators, research staff, and the Safety Monitoring Committee
- Review informed consent forms, source documents, trial records, and CRFs for accuracy, completeness, legibility, and consistency
- Report protocol, SOP, GCP, and regulatory deviations and implement appropriate corrective measures
- Assess whether adverse events are reported within required timeframes
- Arrange compliance monitoring visits and assess site procedures and GCP adherence
- Escalate quality concerns and support corrective-action efforts
- Support study teams preparing for external audits and participate in internal reviews at affiliate institutions when needed
- Educate investigators, clinical sites, and coordinators about remote monitoring and remote data entry
- Travel occasionally for monitoring visits
Талаптар
- Bachelor’s degree
- Five years of related clinical trial or medical research experience
- Thorough understanding of ICH GCP and FDA guidelines
- Experience with electronic data capture systems
- Exceptional attention to detail when reviewing clinical trial data, source documents, and regulatory compliance
- Additional education may replace required experience, and additional related experience may replace education beyond a high school diploma or equivalent, subject to the JHU equivalency formula
- Preferred: Bachelor’s degree in life sciences, health care, or a related field
- Preferred: Certification in human subjects research
- Preferred: Certified Clinical Research Associate (CCRA) credential
- Preferred: Experience in quality assurance, clinical trial auditing or monitoring, and/or good clinical practice
- Preferred: Experience with REDCap, SharePoint, and eIRB systems
- Intermediate proficiency in clinical documentation review
- Intermediate proficiency in data analysis
- Intermediate proficiency in documentation
- Intermediate proficiency in project management
- Intermediate proficiency in regulatory compliance
- Intermediate proficiency in SOP development
- Intermediate proficiency in training and development
Артықшылықтар
- Total rewards package covering health, life, career, and retirement support
- Seasonal influenza vaccination required by Johns Hopkins University, with religious and medical exemptions available
- Required vaccinations for applicable roles are provided at no cost through Occupational Health
- Pre-employment accommodations are available
- Equal opportunity employment
- Background checks assess justice-involved backgrounds individually