Clinical Study Monitor in Marlborough, Massachusetts at BTL Industries Inc

The Clinical Research Associate (CRA) / Clinical Study Monitor is responsible for ensuring the quality, integrity, and regulatory compliance of company-sponsored clinical studies conducted across multiple research sites throughout the United States and Canada.

This role is heavily focused on site monitoring, source document verification, regulatory documentation review, study binder management, protocol compliance, data quality auditing, and investigator-site support. The ideal candidate is highly detail-oriented, organized, and experienced in monitoring clinical studies in accordance with ICH-GCP, IRB requirements, company SOPs, and applicable regulations.

This position requires extensive travel to clinical research sites and regular interaction with Principal Investigators (PIs), study coordinators, and clinical site personnel.

Primary Responsibilities

Clinical Monitoring

• Conduct Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs).
• Review source documentation, informed consent forms, CRFs, regulatory binders, delegation logs, device accountability records, and study documentation for completeness and accuracy.
• Verify protocol compliance and ensure studies are conducted according to approved protocols and regulatory requirements.
• Identify protocol deviations, documentation deficiencies, and compliance issues and assist sites with corrective actions.
• Prepare detailed monitoring reports, follow-up letters, and site visit documentation.

Regulatory Documentation & Compliance

• Review and maintain investigator site files, regulatory binders, essential documents, and Trial Master File (TMF) documentation.
• Ensure study records remain inspection-ready and audit-ready at all times.
• Verify IRB approvals, continuing reviews, amendments, investigator documentation, and regulatory correspondence are current and properly maintained.
• Support preparation for sponsor audits, regulatory inspections, and internal quality reviews.

Data Verification & Quality Control

• Perform source document verification (SDV) and data review activities.
• Audit CRFs, electronic databases, patient records, and study documentation for completeness and accuracy.
• Identify data discrepancies and coordinate query resolution with study sites.
• Monitor data quality and ensure timely and accurate study documentation.

Site Support & Communication

• Serve as a primary monitoring contact for investigators and study coordinators.
• Provide study-specific training and guidance related to protocol compliance and documentation requirements.
• Track site performance, enrollment progress, monitoring schedules, and outstanding action items.
• Coordinate study-related communications between sites and internal Clinical Affairs personnel.

Clinical Trial Operations Support

• Assist with site activation activities and study startup requirements.
• Coordinate shipment, tracking, accountability, and reconciliation of study devices and materials.
• Support study closeout activities and final documentation review.
• Assist with collection and organization of clinical data for publications, presentations, and scientific reporting.

Required

• Bachelor's degree in Life Sciences, Nursing, Healthcare, Biomedical Sciences, Public Health, or related field.
• 2–5 years of experience as a Clinical Research Associate (CRA), Clinical Monitor, Clinical Research Coordinator, or similar clinical research role.
• Experience conducting on-site monitoring visits and reviewing clinical research documentation.
• Working knowledge of ICH-GCP guidelines and clinical research regulations.
• Experience reviewing regulatory binders, informed consent forms, source documents, CRFs, and study files.
• Strong auditing, documentation review, and problem-solving skills.
• Exceptional attention to detail and organizational abilities.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple study sites simultaneously.
• Proficiency with Microsoft Office Suite and electronic clinical documentation systems.
• Ability to travel 40–50%+ throughout the United States and Canada.

Preferred

• CCRA® (Certified Clinical Research Associate) certification.
• ICH-GCP certification.
• Experience with medical device clinical studies and ISO 14155.