Senior CRA - AI-Driven Clinical Trials (AU-Secret)

Alignerr Corp.; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

Medtronic in Melbourne, Australia, seeks an experienced Senior Clinical Research Monitor (CRA) to lead site monitoring across the full study lifecycle, ensuring safety and data integrity. This on-site role requires strong collaboration with investigators, coordinators and hospitals to drive patient recruitment and study execution.

The candidate will manage site initiation, ethics submissions, and ongoing monitoring, leveraging CTMS/EDC expertise and thorough knowledge of GCP and regulatory

Qualifications

• Bachelor degree with 4+ years of relevant experience or advanced degree with 2+ years experience.
• Experience conducting on-site and remote monitoring visits across multiple studies.
• Familiarity with GCP, ICH guidelines and regulatory requirements.

Responsibilities

• Lead site monitoring activities through study lifecycle including qualification, initiation, interim monitoring and closeout.
• Serve as sponsor contact for assigned sites and maintain investigator relationships.
• Ensure studies are conducted and reported in compliance with protocols, GCP, regulations and SOPs.
• Review documentation, data, deviations, AEs and site performance for safety and data integrity.
• Train investigators and site personnel on protocol requirements and study procedures.

Skills

GCP

ICH Guidelines

CTMS

EDC

Microsoft Office

Investigator relationships

Education

Bachelor's degree in life sciences

Tools

CTMS

EDC

Job description

Medtronic in Melbourne, Australia, seeks an experienced Senior Clinical Research Monitor (CRA) to lead site monitoring across the full study lifecycle, ensuring safety and data integrity. This on-site role requires strong collaboration with investigators, coordinators and hospitals to drive patient recruitment and study execution.

The candidate will manage site initiation, ethics submissions, and ongoing monitoring, leveraging CTMS/EDC expertise and thorough knowledge of GCP and regulatory