Clinical Study Monitor

BTL Industries is hiring a Clinical Study Monitor to ensure the quality, integrity, and regulatory compliance of company-sponsored clinical studies across research sites. The role conducts site monitoring, reviews study documentation and data, supports regulatory readiness, and provides guidance to investigators and study coordinators.

Responsibilities

• 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
• 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
• 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
• 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
• 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

Preferred

• CCRA® (Certified Clinical Research Associate) certification
• ICH-GCP certification
• Experience with medical device clinical studies and ISO 14155
• Experience supporting multi-site clinical trials
• Familiarity with electronic data capture (EDC) systems and clinical data management platforms
• CCRA Certification
• ICH-GCP Certification
• Medical Device Clinical Studies
• ISO 14155
• Multi-Site Clinical Trials
• Electronic Data Capture (EDC)
• Clinical Data Management Platforms

Company

• Medical, physiotherapy, cardiology, and aesthetic equipment manufacturer
• Stevenage, Hertfordshire, GBR
• https://btl.asia/
• Founded in 1993
• 1001-5000 employees

Qualifications

• 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
• CCRA® (Certified Clinical Research Associate) certification
• ICH-GCP certification
• Experience with medical device clinical studies and ISO 14155
• Experience supporting multi-site clinical trials
• Familiarity with electronic data capture (EDC) systems and clinical data management platforms
• 2–5 years of experience as a Clinical Research Associate (CRA), Clinical Monitor, Clinical Research Coordinator, or similar clinical research role.

Required skills

• Case Report Forms (CRFs), Certified Clinical Research Associate (CCRA), Clinical Research Regulations, Clinical Study Monitoring, Electronic Data Capture (EDC), ICH-GCP, ISO 14155, Informed Consent Forms, Medical Device Clinical Studies, Regulatory Documentation Review, Source Document Verification

Preferred skills

• 2026-05-07, 2026-06-02, 2026-10-01, AI Tools, Analyze How Well You Fit, BTL Expands EXOMIND® Platform with New FDA Clearances, Build Cover Letter, CCRA® (Certified Clinical Research Associate) certification, CEO North America, Canada NewsWire, Company data provided by, Customize Your Resume, David Chmel, Experience supporting multi-site clinical trials, ICH-GCP certification, Late Stage, Leadership Team, Make your application stand out, Maximize your interview chances, PR Newswire, PRWeb, Recent News, Stevenage, Hertfordshire, GBR, Understand your strength & weakness, https://btl.asia

Experience

• 2-5 years