Field monitoring of studies and data collection for clinical trials
Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form
Determining if clinical trial/study subject documentation is within parameters of study hypothesis
Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
Providing oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality)
Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external
Auditing to ensure proper regulatory documentation to conduct the trial/study
Validating investigational device accountability by tracking investigational devices from Edwards to the field sites
Developing and delivering training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements
Contributing to the development of clinical protocols, informed consent forms, and case report forms
Editing/amending informed consent documents

Bachelor's Degree or equivalent in related field with 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

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

Clinical Research Monitoring Specialist

Key skills