Senior CRA I/II (Melbourne/Perth) - FSP

About the role

Syneos Health is hiring a Senior Clinical Research Associate (CRA) I/II for its Functional Service Provider (FSP) program, based in Melbourne or Perth. The role covers site qualification, initiation, interim monitoring, site management and close-out, performed on-site or remotely, and may involve mentoring junior CRA staff.

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 such as protocol deviations and pharmacovigilance issues
• Review source documents and medical records, verify CRF data accuracy and completeness, and resolve queries remotely and on site
• Check site compliance with electronic data capture requirements
• Review investigational product inventory, storage and security, and verify IP dispensing and administration per protocol
• Review the Investigator Site File, reconcile it with the Trial Master File and ensure proper archiving
• Document activities, support recruitment and retention, enter data into tracking systems and manage site-level communication
• Act as liaison with study sites, prepare for and attend investigator and sponsor meetings, and guide sites toward audit readiness
• Supervise, train and mentor junior CRA staff, and possibly take part in business development proposals and RFPs
• For Real World Late Phase (RWLP) studies, the role is titled Senior Site Management Associate II and includes site support, chart abstraction, informed consent form development, site selection and bid defence

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other regulatory requirements
• 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%