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We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.\n The Milestone One Site Coordinator role supports a Clinical Study Site in clinical trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.\nThe function of the role may include, but not limited to, any/all of the following:\nAct as the main line of communication between the Sponsor or CRO and the site.\nEnsure response to feasibility questions are provided in due time.\nAssist in scheduling and preparation for all types of monitoring visits at the medical institution/research center.\nBe present and available to respond to monitors during all types of monitoring visits conducted at the medical institution.\nTrack patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals.\nMaintain study specific and general tracking of documents at the site level.\nAccurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site.\nTimely reporting and follow up on Reportable Adverse Events and Protocol Deviations.\nProper handling, accountability and reconciliation of investigational products and clinical supplies.\nCollect, handle and maintain all site-specific regulatory documents as needed.\nFacilitate and support the contract and budget negotiations at the site level.\nSupport Investigator and Site payments and processes as needed.\nSchedule and/or perform study procedures as per study requirements and delegation of responsibilities.\nPrepare for and participate in onsite study audits or regulatory agency inspections.\n A university degree in Life Science, preferably in pharmacy, nursing or lab analytics.\nMinimum of 2 years of on-the-job experience as a site coordinator\nAbility to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously.\nAbility to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner.\nFlexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.\nFluent Polish and English\n If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you.","description_format":"text","description_chars":2573,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"Polish","level":"Advanced (C1)","optional":false},{"language":"English","level":"Advanced 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