Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced professional to oversee and ensure the quality and integrity of clinical research studies focused on advanced cardiac electrophysiology devices. This role involves significant site monitoring, data verification, and collaboration with investigators and site staff, with a focus on cardiac arrhythmia trials.

Responsibilities:

• Oversee site selection, initiation, monitoring, and close-out activities for clinical research studies involving cardiac devices.
• Ensure all clinical studies adhere to approved protocols, ICH-GCP guidelines, and relevant regulatory requirements.
• Verify the accuracy, completeness, and timeliness of clinical trial data collected at study sites.
• Act as a liaison between study sites and internal teams, maintaining regular communication and supporting data collection during procedures.
• Identify, document, and resolve site issues and protocol deviations, escalating as needed to maintain study integrity.
• Support training for new clinical research associates and site staff, and contribute to process improvements and study planning.
• Prepare detailed visit reports and ensure compliance with regulatory documentation and Trial Master File requirements.
• Travel up to 25% to various clinical sites across multiple states to provide on-site monitoring and support.

Qualifications:

• Bachelor’s degree or higher in engineering or a scientific discipline.
• At least 2 years of experience in clinical trial monitoring, preferably with medical devices or diagnostics.
• Experience with cardiac device trials, especially those involving electrophysiology or cardiac arrhythmias, is highly valued.
• Strong knowledge of GCP, ICH guidelines, FDA, and international regulations.
• Proficiency in Microsoft Office Suite and electronic data capture (EDC) systems.
• Familiarity with remote monitoring tools and risk-based monitoring approaches.
• Certification from ACRP or SOCRA is preferred.
• Excellent organizational, communication, and time-management skills, with the ability to travel domestically and internationally up to 25%.

Published Category: Clinical Operations & Development