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

About the role

Syneos Health is hiring a Senior CRA I/II for its Clinical Solutions team, based in Melbourne, Sydney or Brisbane. The role covers site qualification, initiation, interim monitoring, site management and close-out, with the possibility of acting as primary liaison with study sites and supervising junior CRAs. For Real World Late Phase (RWLP) studies, the Sr. CRA II uses the title Sr. Site Management Associate II.

Key responsibilities

• Perform site qualification, initiation, interim monitoring, site management and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP and/or GPP and protocol compliance
• Evaluate site and site staff performance, escalate serious issues and develop action plans
• Verify informed consent, protect subject confidentiality and 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 site compliance with electronic data capture requirements and verify investigational product inventory, dispensing, labelling and release
• Review the Investigator Site File, reconcile it with the Trial Master File and document activities per the Clinical Monitoring Plan/Site Management Plan
• Support recruitment and retention, enter tracking data, prepare for audits and attend investigator and sponsor meetings
• Supervise, train and mentor junior CRAs, and possibly take part in bid defence and RFP work
• RWLP additions: site support through the study lifecycle, chart abstraction, informed consent form development, site selection and site management strategy, and collaboration with the RWLP regulatory team

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of 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%

Required skills

• Knowledge of Good Clinical Practice (ICH-GCP) and other applicable regulatory requirements
• ICH-GCP, CRF review, site management and clinical monitoring