Senior CRA

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Qualifications

Responsibilities

• Work collaboratively with the study teams. review, revision and writing of protocols, and other required documents for clinical research studies
• Reviewing informed consent forms and other Trial Master File (TMF) documents, insuring that all regulatory requirements are met
• Performing site visits as needed, insuring the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements
• Communicating with study centers, addressing issues and disseminating study trial information when needed
• Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events
• Assisting with data flow and query resolution
• Independently oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support

Qualifications

• 5+ years’ experience in medical device class III or parallel
• PhD in relevant field
• Ability to work effectively on a cross-functional team is desired
• GCP license