Clinical Research Associate - Poland

Who We Are

Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms. Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end‑to‑end clinical trial solutions across all phases, offering Phase I‑IV and real‑world studies.

With over 25 years of experience and a world‑renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.

Emerald Clinical is where science, speed, and strategy come together to transform healthcare. For over 25 years, we have led the way in clinical research, combining global reach with deep Asia‑Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.

Our 800+ employees span across Asia‑Pacific, Europe, and the Americas and are embedded in communities worldwide. We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.

The Clinical Research Associate 2 (CRA II) is a member of the Clinical Operations group at Emerald Clinical. The Clinical Operations group is responsible for site management, monitoring tasks, and the operational support of clinical trials. The group allocates resources to projects as appropriate to assist with implementing project plans and to ensure compliance with regulatory requirements and Standard Operating Procedures (SOPs).

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organize, and conduct site evaluation visits and report on these visits to assist in site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organize, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project‑specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines. Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in‑house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.

• Qualifications in a related science or health care discipline.
• Previous experience in clinical trials within an academic, CRO, or pharmaceutical environment with 2-5 years in on‑site monitoring and site management experience is mandatory.
• Experience with renal/nephrology and oncology studies.
• Demonstrate practical knowledge of ICH‑GCP guidelines and global and local ethical and regulatory research requirements.
• Display competence in the following technical areas: ethical and participant safety considerations, site start‑up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate competence in the following business skill areas: negotiation and conflict resolution, critical thinking, problem‑solving, decision making, and strategic thinking.
• Demonstrate solid interpersonal communication, presentation…