Senior Clinical Research Associate I/II (Melbourne/Sydney/Brisbane)

About the role

Syneos Health is hiring a Senior Clinical Research Associate (SCRA) I/II for Melbourne, Sydney or Brisbane-based clinical studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, in line with regulatory, ICH-GCP and Good Pharmacoepidemiology Practices (GPP) requirements.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, evaluating site performance and escalating serious issues
• Verify informed consent and protect subject confidentiality; assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries within agreed timelines
• Check electronic data capture compliance and, where applicable, review investigational product inventory, dispensing and labelling
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure document archiving complies with local rules
• Support subject recruitment and retention, enter tracking data, and prepare for audits
• Act as liaison with study sites, attend investigator and sponsor meetings, and supervise or mentor junior CRAs
• For Real World Late Phase (RWLP) studies, support site selection, chart abstraction, informed consent forms, bid defence and RFP input, and suggest sites based on local knowledge

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills; moderate critical thinking
• Able to travel regularly up to 75%