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
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