Note: The job is a remote job and is open to candidates in USA. Edwards Lifesciences is seeking a Specialist, Clinical Research Monitoring to support its Clinical Affairs team. The role focuses on field monitoring of clinical studies, data verification, regulatory documentation, investigational device accountability, and training to ensure compliance with GCP and regulatory requirements.

Responsibilities

• 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, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as 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) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommending and developing process improvements
• Verifying trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded
• Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition
• Developing and delivering training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities

Skills

• 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)
• 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

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

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