CRA II – Sponsor-dedicated (Poland)

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 nursing qualification, or equivalent combination of education and experience
• Working knowledge of ICH Good Clinical Practice guidelines and applicable regulatory requirements
• Solid computer skills and genuine willingness to adopt new technologies
• Excellent oral and written communication; strong presentation and interpersonal abilities
• Capacity to undertake travel up to 75% of the time to support site monitoring visits and meetings

Working at Syneos Health India Private Limited

We are committed to advancing healthcare and accelerating progress for patients globally. With 25,000 colleagues worldwide, we have supported clinical development across 73,000 investigator sites, involving more than 675,000 trial participants and spanning over 200 studies in the past five years. We partner with 94% of newly FDA-approved therapeutics and 95% of EMA-authorised products. We invest in your professional growth through targeted development programmes, specialised training in clinical and therapeutic domains, and a genuinely inclusive culture where you can bring your authentic self to work each day.

Applying for This Role

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