Site Coordinator
On-siteOlsztyn, Warmia-Masuria, Poland
Job Summary
Act as the primary communication link between the Sponsor/CRO and the clinical site, ensuring timely responses to feasibility questions and protocol requirements. Coordinate scheduling and preparation for all monitoring visits, while being present to respond to monitors and facilitate contract and budget negotiations. Track patient enrollment, maintain study-specific document tracking, and ensure accurate data entry into EDC systems with timely query resolution. Manage reportable adverse events and protocol deviations, handle investigational product accountability, and support site audits or regulatory inspections. Schedule and perform study procedures as delegated, manage site payments, and collect regulatory documents. Requires fluent English and Polish, with flexibility for varying hours to support study timelines.
Required Qualifications
- Act as the main line of communication between the Sponsor or CRO and the site
- Ensure response to feasibility questions are provided in due time
- Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center
- Be present and available to respond to monitors during all types of monitoring visits conducted at the medical institution
- Track patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals
- Maintain study specific and general tracking of documents at the site level
- Accurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site
- Timely reporting and follow up on Reportable Adverse Events and Protocol Deviations
- Proper handling, accountability and reconciliation of investigational products and clinical supplies
- Collect, handle and maintain all site-specific regulatory documents as needed
- Facilitate and support the contract and budget negotiations at the site level
- Support Investigator and Site payments and processes as needed
- Schedule and/or perform study procedures as per study requirements and delegation of responsibilities
- Prepare for and participate in onsite study audits or regulatory agency inspections
- A university degree in Life Science, preferably in pharmacy, nursing or lab analytics
- Minimum of 2 years of on-the-job experience as a site coordinator
- Ability to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously
- Ability to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner
- Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits
- Fluent Polish and English
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