Senior CRA I/II - FSP (Remote/On-site)

Syneos Health, Inc.; Melbourne, Sydney, Brisbane; On-site; AUD 90,000 - 130,000; Full time

Job summary

Syneos Health in Australia is seeking a Senior CRA I/II for Melbourne/Sydney/Brisbane to monitor clinical trials on-site and remotely, ensuring ICH-GCP compliance and high data quality. The role involves site qualification, initiation, monitoring, IP handling, and study team collaboration.

The successful candidate will hold a Bachelor’s degree or nursing qualification, demonstrate strong communication skills, and be prepared to travel up to 75% across study sites in Australia.

Qualifications

• Bachelor’s degree or RN; regulatory and GCP knowledge required.
• Willingness to travel up to 75% as part of site monitoring.
• Strong communication and problem-solving skills for site management.

Responsibilities

• Performs site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent processes and protects confidentiality of subjects.
• Reviews ISF, TMF, and archiving requirements; supports recruitment and data tracking.
• May handle IP inventory, reconciliation and data/labeling controls per protocol.
• Participates in Investigator Meetings and sponsor meetings; supports audit readiness.

Skills

GCP knowledge

Clinical monitoring

Site management

Data quality review

Education

Bachelor’s degree or RN

Job description

Syneos Health in Australia is seeking a Senior CRA I/II for Melbourne/Sydney/Brisbane to monitor clinical trials on-site and remotely, ensuring ICH-GCP compliance and high data quality. The role involves site qualification, initiation, monitoring, IP handling, and study team collaboration.

The successful candidate will hold a Bachelor’s degree or nursing qualification, demonstrate strong communication skills, and be prepared to travel up to 75% across study sites in Australia.