Clinical Research Monitor

The Johns Hopkins University; Baltimore (MD); On-site; USD 55,000 - 98,000; Full time

Job summary

An established industry player is seeking a Clinical Research Monitor to lead compliance monitoring for multi-centered clinical trials. This role involves ensuring the quality and integrity of clinical trial data through a risk-based approach. The successful candidate will collaborate with clinical trial teams nationwide, manage site progress, and ensure adherence to regulatory standards. If you have a passion for clinical research and compliance, this opportunity offers a chance to make a significant impact in the field of medical research.

Qualifications

• 5+ years of experience in clinical trials or medical research.
• Knowledge of ICH GCP and FDA guidelines.

Responsibilities

• Manage site and study progress, ensuring compliance and data integrity.
• Develop monitoring plans based on risk assessments and conduct audits.

Skills

Clinical Trials Management

Regulatory Compliance

Data Analysis

Medical Terminology

IRB Policies

Education

Bachelor’s Degree in a related field

Tools

Microsoft Office

SharePoint

REDCap

Job description

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The Department of Neurology, BIOS Clinical Trials Coordinating Center (CTCC) is seeking a Clinical Research Monitor (CRM) who will take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS CTCC policies and procedures and GCP. The Compliance Monitoring Specialist will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials through utilization of a risk-based, remote monitoring approach. In collaboration with clinical trial teams across the country, support the clinical trial research goals of the BIOS Clinical Trials Coordinating Center’s (CTCC) by monitoring numerous centers’ trial cycle metrics, protocol fidelity, and overseeing regulatory compliance.

Specific Duties & Responsibilities

1. Manage site and study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
2. Participate in risk assessments by reviewing new studies for quality assurance and content.
3. Develop monitoring plans based on risk assessments.
4. Ensure collection and maintenance of essential documents and their delivery to the Trial Master File.
5. Assist in training new research staff on research compliance.
6. Generate queries, follow-up on non-compliance, and communicate findings.
7. Verify informed consent, source documents, and CRFs for accuracy and completeness.
8. Report deviations from protocols and regulatory requirements, and take corrective actions.
9. Monitor adverse events reporting and compliance visits.
10. Assist in preparing for audits and participate in reviews.
11. Educate staff on remote monitoring and data entry.
12. Travel for monitoring visits as needed.
13. Other duties as assigned.

Additional Knowledge, Skills, and Abilities

• Knowledge of medical terminology and human subject research.
• Experience with IRB policies and submissions.
• Proficiency in Microsoft Office, SharePoint, and REDCap (preferred).
• Ability to learn new software tools.

Minimum Qualifications

• Bachelor’s Degree in a related field.
• At least 5 years of experience in clinical trials/medical research.
• Knowledge of ICH GCP and FDA guidelines.
• Experience with EDC systems.

Preferred Qualifications

• BA/BS in medical research or related discipline.
• Certified Clinical Research Associate (CCRA).
• Experience with quality assurance or clinical trial auditing/monitoring.

Classified Title: Sr. Compliance Monitoring Specialist
Job Posting Title: Clinical Research Monitor
Role/Level/Range: ACRP/04/MD
Salary Range: $55,800 - $97,600 (dependent on experience)