Overview
Location: Adelaide, SA, Australia | Job ID: 25109229
Syneos Health is a fully-integrated life sciences services organization that partners with innovators across the drug development and commercialization continuum to accelerate progress. Our Clinical Solutions team applies a drug development mindset to understand customer needs and shape solutions. Roles may be in Functional Service Provider partnerships or Full-Service environments, with collaboration across problem solvers to deliver value for customers and patients.
Job Responsibilities
* Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site and site staff performance and provides recommendations; communicates/escalates serious issues to the project team and develops action plans. Maintains knowledge of ICH/GCP or other applicable guidance, regulations, and SOPs/processes.
* Verifies informed consent is properly obtained/documented; protects subject confidentiality. Assesses factors affecting subject safety and data integrity at investigator/physician sites (e.g., protocol deviations, violations, pharmacovigilance issues).
* Assesses site processes per the Clinical Monitoring/Site Management Plan (CMP/SMP). Conducts source document review, verifies CRF data accuracy/completeness, resolves data queries remotely and on-site, and guides site staff to closure within timelines. Utilizes hardware/software to support data review and capture; ensures site compliance with electronic data capture requirements.
* May perform investigational product (IP) inventory, reconciliation, storage and security. Verifies IP dispensing per protocol; manages issues/risks related to blinded or randomized IP information. Ensures IP labelling, importation and release/return in compliance with GCP/local regulations.
* Routinely reviews Investigator Site File (ISF) for accuracy and timeliness; reconciles with Trial Master File (TMF). Ensures archiving of essential documents per local guidelines and regulations.
* Documents activities via letters, trip reports, logs, and other project documents; supports recruitment, retention and awareness strategies. Enters data into tracking systems to monitor observations, status, and action items.
* Understands project scope, budgets, and timelines; manages site-level activities and communications to meet objectives. Adapts to changing priorities to achieve goals/targets.
* May act as primary liaison with study site personnel or with Central Monitoring. Ensures training and compliance of assigned sites and project-specific team members.
* Prepares for and attends Investigator Meetings and sponsor meetings. Participates in global clinical monitoring/project meetings and attends required training per project requirements.
* Provides guidance toward audit readiness and supports preparation for audits and follow-up actions.
* Maintains knowledge of ICH/GCP guidelines, regulations, and SOPs; completes assigned training. For Real World Late Phase, may hold the Site Management Associate II title; duties include site support throughout the study lifecycle, chart abstraction, collaboration with sponsor affiliates, MSLs and local staff, training junior staff, and identifying out-of-scope activities.
Qualifications
* 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 regulatory requirements
* Strong computer skills and adaptability to new technologies
* Excellent communication, presentation and interpersonal skills
* Ability to travel up to 75% regularly
* US ONLY: Compliance with site access requests and information sharing as part of employment; failure to provide requested information may affect site access
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