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
Associate Clinical Research Associate (Internal Studies)
Builds
Internal clinical studies for medical devices and diagnostics
Domain
Medical Devices / In-vitro Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial data management, informed consent procedures, site visit execution, regulatory compliance (CFR, ICH-GCP), study file maintenance, data accuracy review, device accountability, case report form design assistance, audit support
Preferred skills
Medical device study experience, in-vitro diagnostics experience, pharmaceutical background
Technologies
Microsoft Suite
Responsibilities
Perform internal clinical studies, recruit study participants, conduct informed consent discussions, record study data, maintain study files, coordinate study start-up and close-out, perform site visits (SQV, SIV, IMV, COV), generate monitoring reports, track action item resolution, assist in developing monitoring plans and CRFs, maintain and audit Trial Master File (TMF), review clinical data listings for completeness and accuracy, participate in interim and final data reviews, interact with RA/QA for audits and FDA inquiries
Seniority
Entry-level (0-1 year experience)
