Clinical Research Associate
Core
Act as a clinical site monitor for in vitro diagnostic (IVD) medical device clinical studies, ensuring compliance with protocols and regulations.
Role type
Senior Clinical Research Associate (IVD Medical Devices)
Builds
In vitro diagnostic medical device clinical trials
Domain
Life Sciences / Medical Devices / Clinical Research
Deliverable
client delivery
Required skills
Site qualification and setup, Source document verification, Protocol deviation resolution, Ethics committee coordination, Regulatory binder reconciliation, Case report form design, Adverse event reporting, Training study teams
Preferred skills
Risk-based monitoring, Data query resolution, Investigator meeting facilitation
Technologies
ICH-GCP, ISO 14155
Responsibilities
Qualify investigational sites, Conduct site monitoring per protocol, Prepare study monitoring reports, Collect site documents for Sponsor records, Reconcile regulatory binders, Coordinate with ethics committees, Present and train study protocols
Seniority
Senior, hands-on IC