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

About the role

Syneos Health is hiring a Senior Clinical Research Associate (SCRA) I/II, based in Melbourne, Sydney or Brisbane, to carry out site management and clinical monitoring for clinical studies. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely. For Real World Late Phase (RWLP) studies, the position is titled Sr. Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• 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 proper archiving
• Support subject recruitment and retention, enter tracking data, and prepare for audits
• Manage site-level activities and communication, and act as liaison with study sites or with a Central Monitoring Associate
• Prepare for and attend investigator meetings, global clinical monitoring meetings and clinical training sessions
• Supervise, train and mentor junior CRAs, and may be mentored by an experienced Clinical Operations Lead
• RWLP duties: site support throughout the study lifecycle, chart abstraction, informed consent form development, site selection and bid defence participation

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
• Ability to travel regularly up to 75%