Senior Specialist, Clinical Research Monitoring
Core
Field monitoring of clinical trials to ensure data consistency, safety, and regulatory compliance for medical device studies.
Role type
Senior Clinical Research Monitor (CRA)
Builds
Clinical trial evidence supporting medical device safety and effectiveness
Domain
Medical devices / Clinical Research
Required skills
Field monitoring, Quality assurance/control, Regulatory compliance, GCP knowledge, Protocol adherence, Data verification, Investigational device accountability, Training delivery, Source documentation auditing, Informed consent editing
Preferred skills
Clinical research certification (ACRP/SoCRA), Medical device trial experience, Cardiovascular anatomy/pathology/physiology knowledge, Technical writing, Problem-solving, MS Office Suite proficiency
Technologies
MS Office Suite (Word, Excel, Adobe), General computer software
Responsibilities
Conduct field monitoring of clinical trials and assess data documentation for consistency with case report forms; Develop and deliver technical training on GCPs, protocols, and compliance to staff and new employees; Provide oversight of trial activities including protocol compliance trends and data quality; Validate investigational device accountability from warehouse to field sites; Verify trial data and audit regulatory documentation at study sites; Edit and amend informed consent documents.