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 or 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/or Good Pharmacoepidemiology Practice (GPP) and protocol 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 completeness, and resolve queries within agreed timelines
• Check site compliance with electronic data capture requirements and verify investigational product inventory, dispensing and administration
• Review the Investigator Site File and reconcile it with the Trial Master File
• Support subject recruitment, retention and awareness, and enter observations and action items into tracking systems
• Manage site-level activities and communication, and act as liaison with site personnel or with a Central Monitoring Associate
• Prepare for and attend investigator meetings and sponsor meetings, and support audit readiness
• Mentor or train junior CRAs, and may be mentored by an experienced Clinical Operations Lead
• For Real World Late Phase studies: site support throughout the study lifecycle, chart abstraction, data collection, informed consent form development, and collaboration with the regulatory team and affiliates

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to manage regular travel of up to 75%

Required skills

• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills
• Basic critical thinking skills