Clinical Operations Coordinator
Core
Supporting the planning, coordination, and operational execution of clinical investigations for a precision neurology company using graphene-based neural systems.
Role type
Clinical Operations Coordinator
Builds
Clinical investigations and investigator-initiated studies for neural network modulation devices
Domain
Medical devices / Precision neurology / Graphene technology
Required skills
Clinical trial coordination, Study start-up management, CRO and vendor coordination, Trial Master Files (TMF) management, ICH-GCP compliance, ISO 14155 and MDR knowledge, Clinical data review support, Operational reporting, SOP development
Preferred skills
Medical device clinical research experience, EDC systems experience, Investigational site management
Technologies
EDC systems
Responsibilities
Support planning and coordination of clinical investigations and investigator-initiated studies; Assist with study start-up, study tracking, and operational activities; Coordinate interactions with CROs, vendors, and investigational sites; Manage and maintain study documentation and Trial Master Files (TMF); Contribute to compliance with ICH-GCP, ISO 14155, MDR, and internal procedures; Support clinical data review and data quality activities; Prepare study status updates, reports, and operational metrics; Contribute to the development and continuous improvement of clinical SOPs and operational processes.