Specialist, Clinical Research Monitoring
Core
Field monitoring of clinical trials for Transcatheter Heart Valve (THV) devices to ensure data consistency, safety, and regulatory compliance.
Role type
Specialist, Clinical Research Monitoring (CRA)
Builds
Clinical evidence for minimally invasive cardiovascular therapies
Domain
Medical devices / Structural heart disease / Cardiovascular care
Deliverable
client delivery
Required skills
Field monitoring, data collection, regulatory compliance (GCP), source documentation verification, device accountability tracking, training delivery, protocol adherence
Preferred skills
Clinical research certification (ACRP/SoCRA), cardiovascular anatomy/pathology/physiology knowledge, medical device regulatory expertise, technical writing, adverse event reporting
Technologies
MS Office Suite (Word, Excel, Adobe)
Responsibilities
Monitor clinical trial sites for protocol and GCP compliance; verify trial data and source documentation; track investigational device accountability; provide oversight on trial activities and data quality; deliver training on GCPs, protocols, and compliance requirements.
Seniority
Mid-level Specialist