Senior Compliance Monitoring Specialist, Neurology

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🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $57.2k - $100k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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JHU EEHPC

WebsiteLinkedInAll Job Openings

11 - 50 employees

📚 Education

🤖 Artificial Intelligence

🏥 Healthcare

Education • Artificial Intelligence • Healthcare

JHU EEHPC is the Energy Efficient High Performance Computing Lab at Johns Hopkins University, led by Tinoosh Mohsenin. The lab focuses on designing medical, health, and wearable devices and developing tiny, energy-efficient wearable and mobile computing systems through cross-layer approaches spanning algorithms, architecture, hardware, and system integration. It applies high-performance computing and artificial intelligence methods to smart health monitoring, robotics, autonomous navigation, and related domains, aiming to revolutionize healthcare, transportation, and public utilities.

📋 Description

• 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

• 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

• 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