Senior Specialist, Clinical Research Monitoring

We're dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR). Our Transcatheter Heart Valve (THV) business unit brings together Clinical Affairs, Engineering, and Research professionals to design and develop minimally invasive therapies that impact patient outcomes and quality of life. We're working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease.

How you will make an impact:

• 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.
• Developing and delivering technical 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. Acting as a mentor to new or junior level employees.
• 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 Boards, Contract, and Training, developing process improvements.
• Contributing to the development of clinical protocols, informed consent forms, and case report forms.
• Validating investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition.
• 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.
• Editing/amending informed consent documents.

What you'll need (Required):

• Bachelor's Degree or equivalent in related field with 5 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.

What else we look for (Preferred):

• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification.
• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills.
• Demonstrated problem-solving and critical thinking skills.
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery.
• Excellent understanding of cardiovascular anatomy, pathology, and physiology or Business Unit area of expertise.
• Moderate 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.
• Experience in training new hires.