Remote Clinical Trials Compliance Lead – Neurology

The Johns Hopkins University; Baltimore (MD); Remote; USD 57,000 - 100,000; Full time

Job summary

The Johns Hopkins University, Department of Neurology, BIOS Clinical Trials Coordinating Center (CTCC), seeks a Sr. Compliance Monitoring Specialist to lead remote monitoring of multicenter trials under GCP and BIOS policies.

You will manage regulatory submissions, risk assessments, monitoring plans, and source document validation; train staff; generate monitoring reports; coordinate with investigators; and prepare for external audits. Remote work with minimal travel.

Qualifications

• 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, to the extent permitted by the JHU equivalency formula.

Responsibilities

• Track regulatory submissions, recruitment, CRF completion, and data query resolution.
• Participate in risk assessments by reviewing new studies for quality assurance and general content.
• Develop standard and protocol specific forms and trial specific monitoring plans based on risk assessment.
• Ensure collection and maintenance of required essential documents and deliver to Trial Master File.
• Assist in training new research staff regarding research compliance, including presentations sessions.
• Generate queries and conduct follow-up for non-compliance issues; generate monitoring summary reports and communicate findings.
• Verify informed consent, source documents, trial records, and CRFs are accurate, complete, and legible.
• Communicate deviations and take action to prevent recurrence.
• Determine whether adverse events are appropriately reported within required timeframes.
• Schedule compliance monitoring visits and escalate quality issues as appropriate.
• Assist staff with corrective actions and external audits; participate in internal reviews.
• Educate investigators and sites on remote monitoring and data entry.
• Travel for monitoring visits is expected to be minimal.
• Other duties as assigned.

Skills

Regulatory compliance

Data analysis

Documentation

Project management

Training & development

Quality assurance

GCP knowledge

Education

Bachelor's degree

Life Sciences degree or related field

Tools

REDCap

SharePoint

eIRB systems

Job description

The Johns Hopkins University, Department of Neurology, BIOS Clinical Trials Coordinating Center (CTCC), seeks a Sr. Compliance Monitoring Specialist to lead remote monitoring of multicenter trials under GCP and BIOS policies.

You will manage regulatory submissions, risk assessments, monitoring plans, and source document validation; train staff; generate monitoring reports; coordinate with investigators; and prepare for external audits. Remote work with minimal travel.