Clinical Research Associate I
Core
Ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of internal medical device and in-vitro diagnostics studies.
Role type
Junior Clinical Research Associate (Internal Studies)
Builds
Internal clinical studies for medical devices and diagnostics
Domain
Healthcare / Medical Devices / In-vitro Diagnostics
Deliverable
client delivery
Required skills
Clinical trial monitoring, site management, regulatory compliance (CFR, ICH-GCP), data review, TMF management, study startup coordination
Preferred skills
Medical device study experience, in-vitro diagnostics experience, pharmaceutical background
Technologies
Microsoft Suite
Responsibilities
Recruit study participants and conduct informed consent discussions; perform site visits (SQV, SIV, IMV, COV) and generate monitoring reports; coordinate internal studies from start to close-out; maintain and audit Trial Master File (TMF); review clinical data listings for completeness and accuracy; assist in developing monitoring plans and case report forms.
Seniority
Entry-level (0-1 year experience)