Compliance Monitoring Specialist – Neurology

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🕒 Setembro 22

🦀 Maryland – Remoto

🦀 Maryland – Remote

💵 $49.200 - $86.200 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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JHU EEHPC

SiteLinkedInTodas as Vagas

11 - 50 funcionários

📚 Educação

🤖 Inteligência Artificial

🏥 Saúde

Education • Artificial Intelligence • Healthcare

JHU EEHPC é o Laboratório de Computação de Alto Desempenho e Eficiência Energética da Universidade Johns Hopkins, liderado por Tinoosh Mohsenin. O laboratório se concentra no design de dispositivos médicos, de saúde e vestíveis e no desenvolvimento de sistemas de computação móveis e vestíveis pequenos e energeticamente eficientes, através de abordagens de camadas cruzadas que englobam algoritmos, arquitetura, hardware e integração de sistemas. O laboratório aplica métodos de computação de alto desempenho e inteligência artificial para monitoramento de saúde inteligente, robótica, navegação autônoma e domínios relacionados, com a proposta de revolucionar os setores de saúde, transporte e serviços públicos.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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