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 dispensing and administration according to the protocol
• Review the Investigator Site File, reconcile it with the Trial Master File, and ensure proper archiving of documents
• Document activities via confirmation letters, trip reports, communication logs and other project documents, and enter data into tracking systems
• Manage site-level activities and communication so project objectives, deliverables and timelines are met, and adapt quickly to changing priorities
• Act as primary liaison with study sites or work with a Central Monitoring Associate, and prepare for and attend investigator and sponsor meetings
• Support audit readiness and provide guidance to sites
• Supervise, train and mentor junior CRAs, and may be mentored by an experienced Clinical Operations Lead
• 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, bid defence and RFP input

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
• Good computer skills and willingness to adopt new technologies
• Excellent communication, presentation and interpersonal skills, with moderate critical thinking
• Ability to manage travel of up to 75% regularly