Clinical Research Monitor

Clinical Research Monitor

This fully remote Clinical Research Monitor role focuses on supporting IND-regulated clinical trials within an academic research environment. The position centers on risk-based monitoring, Trial Master File (TMF) management, and ensuring adherence to FDA regulations, IND/IDE requirements, and Good Clinical Practice (GCP) guidelines. You will work autonomously while collaborating closely with research, regulatory, and compliance leaders to support high-profile breast imaging and interventional breast procedure studies.

This newly created role offers significant visibility, strong potential for extension beyond the initial contract term, and the opportunity to gain valuable experience in IND-regulated clinical research.

Responsibilities

• Perform independent clinical research monitoring activities for IND-regulated studies, ensuring compliance with FDA regulations, GCP guidelines, and institutional policies.
• Apply risk-based monitoring methodologies to plan, prioritize, and conduct monitoring activities efficiently and effectively across assigned studies.
• Create, implement, and maintain study-specific monitoring plans that align with protocol requirements, regulatory expectations, and risk-based strategies.
• Manage and oversee Trial Master File (TMF) documentation, ensuring completeness, accuracy, and timely filing of essential documents.
• Conduct detailed chart reviews, data reviews, and source data verification to ensure data integrity, protocol adherence, and accurate data entry.
• Prepare clear, comprehensive monitoring reports and follow-up documentation that summarize findings, identify issues, and recommend corrective actions.
• Maintain regulatory files and study documentation in accordance with applicable regulations, institutional standards, and sponsor requirements.
• Collaborate closely with research, regulatory, and compliance teams to support IND oversight and address monitoring, documentation, and regulatory needs.
• Participate in screening and data management activities as needed to support study conduct and ensure high-quality data collection.
• Support the conduct of high-quality interventional breast procedures research, including studies involving stereotactic, ultrasound-guided, and MRI-guided biopsies.
• Communicate proactively with study teams regarding site performance, protocol deviations, data queries, and required corrective or preventive actions.
• Work with minimal supervision, managing your own workload, timelines, and priorities across multiple concurrent studies.
• Contribute to continuous improvement of monitoring processes, risk-based monitoring approaches, and documentation practices within the research program.
• Engage with key stakeholders during occasional onsite visits for walkthroughs, equipment assessments, or study-specific needs, as required.

Essential Skills

• Bachelor's degree in a scientific discipline or a Registered Nurse (RN) credential combined with clinical research experience.
• 2–4+ years of clinical research monitoring experience, including independent execution of monitoring activities.
• Demonstrated experience with IND-regulated clinical research and a strong understanding of IND/IDE regulations and processes.
• Hands-on experience with risk-based monitoring methodologies in a clinical research setting.
• Proven experience creating and implementing monitoring plans for clinical trials.
• Trial Master File (TMF) management experience, including organization and maintenance of essential documents.
• Strong understanding of FDA regulations and Good Clinical Practice (GCP) guidelines.
• Experience preparing detailed monitoring reports and associated documentation.
• Experience maintaining regulatory files and study documentation in compliance with applicable standards.
• Ability to work with minimal supervision and manage multiple priorities independently.
• Strong organizational skills with attention to detail and accuracy in documentation.
• Effective written and verbal communication skills for interaction with research, regulatory, and compliance stakeholders.
• Clinical research experience in addition to RN credentials for candidates with a nursing background.

Additional Skills & Qualifications

• Experience with in an academic medical center or research institution environment.
• Background in clinical research data management, including data entry, data review, and query resolution.
• Familiarity with chart review and screening processes in clinical research.
• Knowledge of FDA processes related to IND oversight and…