Anteris Technologies

Research Analyst

• Oversee CRO and vendor activities, while also directly contributing to study start-up and conduct activities (e.g., site specific ICF review, essential document review, progress tracking)
• Conduct site initiation and monitoring visits; train and support site personnel on sponsor and regulatory requirements; lead or participate in investigator meetings; prepare or review detailed visit reports and documentation
• Serve as sponsor liaison for assigned research institutions, providing guidance and support to research teams from study start up through close out
• Verify accuracy and completeness of clinical data, source documentation, and regulatory files, ensuring compliance with study protocols, SOPs, GCP, PHI, and global regulations
• Identify, investigate, and resolve discrepancies in study documentation; implement corrective and preventive actions to reduce recurrence
• Mentor junior team members, potentially including oversight and/or management of up to 3 CRAs
• Review and maintain Trial Master File (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (FDA, ISO, OUS)
• Partner with cross-functional teams to support site activation, enrollment progress, and data cleaning in alignment with study timelines

Senior Clinical Research Associate – Medical Devices

• Oversee CRO and vendor activities, while also directly contributing to study start-up and conduct activities (e.g., site specific ICF review, essential document review, progress tracking).
• Conduct site initiation and (co)-monitoring visits; train and support site personnel on sponsor and regulatory requirements; lead or participate in investigator meetings; prepare or review detailed visit reports and documentation.
• Serve as sponsor liaison for assigned research institutions, providing guidance and support to research teams from study start up through close out.
• Verify accuracy and completeness of clinical data, source documentation, and regulatory files, ensuring compliance with study protocols, SOPs, GCP (Good Clinical Practice), GDPR, local and global regulations.
• Identify, investigate, and resolve discrepancies in study documentation; implement corrective and preventive actions to reduce recurrence.
• Review and maintain Trial Master File (TMF) documentation for audit readiness; ensure alignment with Good Documentation Practices and regulatory expectations (e.g., FDA, ISO14155, EU-MDR).
• Partner with cross-functional teams to support site activation, enrollment progress, and data cleaning in alignment with study timelines.

Senior Clinical Research Associate – Medical Devices

Senior Clinical Research Associate – EU, Medical Devices