Clinical Research Associate, Sponsor Dedicated, IVD
Core
Designing, planning, coordinating, and conducting clinical research studies for in vitro diagnostics (IVD) to validate product performance and support regulatory submissions.
Role type
Senior IC Clinical Research Associate (IVD)
Builds
Clinical studies and data for regulatory submissions
Domain
Life Sciences / In Vitro Diagnostics
Required skills
Clinical study design, site monitoring, regulatory compliance (FDA/GCP/IVD directives), data validation, stakeholder communication, problem solving
Preferred skills
CRA certification, Medical technology degree, R&D background
Technologies
Microsoft Word, Excel
Responsibilities
Site selection and study initiation, site monitoring and closeout, resolving discrepancies with investigators, developing SOPs to ensure regulatory adherence, obtaining input from key opinion leaders
Seniority
Mid-level, hands-on IC