Sr. Compliance Monitoring Specialist (Neurology)
J
Johns Hopkins UniversityClinical research
Source API remote eligibility restrictions: United StatesFull-TimeSenior
Salary57,195 - 100,040 USD per year
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Job Details
- Experience
- Five years of related experience with clinical trials/medical research.
- Required Skills
- SharePointQuality Assurance
Requirements
- Bachelor’s Degree.
- Five years of related experience with clinical trials or 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.
- Bachelor's Degree in Life Sciences, Health Care, or a 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 good clinical practice preferred.
- Experience with REDCap, SharePoint, and eIRB systems preferred.
- Minimal travel for monitoring visits is expected.
Responsibilities
- Track regulatory submissions, recruitment, case report form completion, and data query resolution.
- Review new studies for quality assurance and participate in risk assessments.
- Develop standard and protocol-specific forms and trial-specific monitoring plans.
- Ensure essential documents are collected, maintained, and delivered to the Trial Master File.
- Generate queries and monitoring summary reports, and communicate findings to investigators, research staff, and the Safety Monitoring Committee.
- Verify informed consent and review source documents, trial records, and case report forms for accuracy, completeness, and consistency.
- Communicate protocol, SOP, GCP, and regulatory deviations to investigators and take action to prevent recurrence.
- Schedule compliance monitoring visits, evaluate site practices, and escalate quality issues.
- Assist study staff with corrective actions and external audit preparation, and participate in internal reviews as needed.
- Train and educate research staff, principal investigators, clinical sites, and coordinators on research compliance and remote monitoring.
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