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
