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Website: syneoshealthindiaprivate.com
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Join Syneos Health India Private Limited as a Clinical Research Associate II (Sponsor-dedicated) based in Poland, helping ensure clinical trial integrity and regulatory compliance whilst partnering with investigator sites throughout the study lifecycle. About This Position Syneos Health is a leading integrated provider of life sciences services that accelerates drug development and commercialisation worldwide. Our Clinical Solutions team combines deep regulatory expertise with hands-on site management to deliver excellence in clinical research. In this full-time role, you will work directly with investigator sites across Poland to maintain rigorous compliance standards, protect trial integrity, and drive successful study outcomes. Your Responsibilities Execute site qualification, initiation, monitoring and closeout procedures—conducted on-site or remotely—ensuring full adherence to ICH-GCP standards, regulatory frameworks and protocol requirements Verify informed consent processes are appropriately documented; safeguard subject confidentiality and identify factors such as protocol deviations or safety concerns that could jeopardise data quality or participant welfare Review source documentation and case report forms to confirm data accuracy and completeness; apply remote and on-site query resolution techniques to drive timely data clarification Oversee investigational product handling, including inventory verification, storage assessment, dispensing confirmation and compliance with protocol and local regulatory frameworks Maintain Investigator Site Files and reconcile them with the Trial Master File; ensure completeness and regulatory archival compliance across all essential documents Document all monitoring activities via trip reports, correspondence and tracking systems; contribute to subject recruitment and retention initiatives Manage site-level project timelines and communications to achieve study deliverables; adapt priorities flexibly to meet evolving research needs Serve as primary liaison with site personnel, delivering training and ensuring compliance across all assigned investigator sites Attend Investigator Meetings and sponsor-led forums; participate in global clinical monitoring discussions and protocol training sessions Support audit readiness assessments and assist in preparation for regulatory audits For Real World Late Phase studies, responsibilities expand to include: site engagement from identification through final closeout, application of local late-phase study design protocols, chart abstraction and data collection activities, coordination with sponsor affiliates and medical science liaisons, and mentoring of junior team members. What We're Looking For Bachelor's degree in a related field, professional…
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