Clinical Research Monitoring Specialist

Job Description:

• Conduct field monitoring of studies and data collection for clinical trials
• Assess data documentation, reports, records, transcripts, and exam results for consistency with case report forms
• Determine whether clinical trial/study subject documentation aligns with the study hypothesis
• Monitor clinical trial/study safety in accordance with protocols, GCP, and regulatory requirements
• Provide oversight and insights into trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality
• Report findings to principal investigators, support staff, sponsor management, leadership, Institutional Review Boards/Ethics Committees, Research Ethics Committees, and Clinical Operations
• Recommend and develop process improvements
• Verify trial/study data and maintain appropriate internal and external regulatory documents
• Audit sites for appropriate regulatory documentation and proper source documentation
• Validate investigational device accountability from Edwards through field sites and final disposition
• Develop and deliver training on GCPs, protocols, databases, compliance, device accountability, adverse event reporting, investigation protocols, amendments, and regulatory documentation
• Train and proctor new employees on trial- and study-related activities

Requirements:

• Bachelor's Degree or equivalent in related field
• 3 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria
• Ability to travel up to 75% domestically
• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) preferred
• Strong written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Demonstrated problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Substantial understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
• Technical writing skills (protocols, CRF development, study tools)
• Ability to communicate and relate well with key opinion leaders and clinical personnel

Benefits:

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families