Central Monitor

We are seeking an experienced Central Monitor to drive risk-based quality management and centralized monitoring strategies for clinical trials. This role is fully remote and offers an opportunity to work on high-impact projects across multiple therapeutic areas, including infectious disease, oncology, and medical devices. The ideal candidate will serve as a Subject Matter Expert (SME), providing leadership, mentorship, and client-facing guidance on best practices for centralized monitoring. This role will be Monday-Friday 8-5 PM EST nd requires that the individual be in one of these states: AZ, CA, DC, FL, GA, IA, IL. KS, MA, MD, NC, TN, TX, VA, WA, WV

Key Responsibilitie of the Central Monitor:

Develop and own risk-based quality management and centralized monitoring processes, templates, and tools for clinical trials.

Review protocols to ensure KRIs and QTLs are standardized and reporting requirements are met.

Lead study risk assessments and propose protocol-specific risk indicators for centralized monitoring.

Support setup and testing of centralized monitoring data analysis platforms.

Review clinical study data, identify site performance issues, and recommend targeted actions to CRAs.

Train and support project teams on interpreting central monitoring signals and decision-making for study conduct.

Manage operational risk logs and ensure compliance with Clinical Risk Management activities.

Perform central monitoring activities, including dashboard reviews, signal management, and action follow-up.

Serve as SME during dashboard development and implementation, advising clients and sponsors on best practices.

Communicate effectively with CRAs, Clinical Project Managers, Trial Managers, and Data Analytics teams.

Ensure adherence to regulatory requirements (FDA, ICH GCP) and internal quality standards.

Contribute to corporate initiatives such as SOP development, process improvement, and proposal support.

Support inspection readiness and assist with audits and post-inspection activities.

Qualifications of the Central Monitor:

• Thorough knowledge of ICH GCP and regulatory requirements for clinical trials, with emphasis on Risk-Based Quality Management and Central Monitoring.
• Minimum 3 years of experience in central monitoring within a CRO setting.
• Prior experience as a CRA conducting on-site monitoring or equivalent skillset.
• Strong understanding of central monitoring database technologies and processes.
• Experience mentoring teams, writing procedures, and advising on best practices.
• Excellent facilitation, presentation, and problem-solving skills; ability to manage shifting priorities.
• Background in infectious disease or oncology trials, or prior work on government contracts, is a plus.

Compensation & Benefits for the Central Monitor:

• Competitive Salary: $85,000–$120,000, with flexibility for highly qualified candidates.
• Fully remote role with long-term project stability.
• Opportunity to work on diverse therapeutic areas and high-profile clinical programs.
• Full health,dental, vision, 401k, PTO, holidays, and sick leave

Applications for this role will be accepted for at least 30 days after the date of posting (12/12).

Keywords: Central Monitoring, Risk-Based Quality Management, Clinical Trials, ICH GCP, KRIs, QTLs, CRO, Remote Role, Clinical Risk Management, Regulatory Compliance, Data Analysis, Oncology, Infectious Disease

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