Clinical Research Associate II - SCRA I (Home Based, Melbourne/Sydney)

About the role

Syneos Health is hiring a Clinical Research Associate II (SCRA I) for a home-based position covering Melbourne and Sydney. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and includes chart abstraction and data collection for Real World Late Phase studies.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and GPP compliance
• Verify informed consent, protect subject confidentiality and assess factors affecting safety and data integrity
• Review source documents and medical records, verify CRF accuracy and resolve queries within agreed timelines
• Check electronic data capture compliance and, where needed, investigate investigational product inventory, dispensing and administration
• Review the Investigator Site File and reconcile it with the Trial Master File
• Support site recruitment and retention, enter tracking data and prepare for audits
• Act as liaison with site personnel, attend investigator and sponsor meetings, and mentor or train junior CRA staff
• For Real World Late Phase studies: site support throughout the lifecycle, chart abstraction, data collection, informed consent form development and bid defence participation

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice and ICH guidelines and other regulatory requirements
• Ability to manage regular travel of up to 75%
• Excellent communication, presentation and interpersonal skills, and basic critical thinking

Required skills

• Good computer skills and willingness to adopt new technologies
• ICH-GCP knowledge