PMilestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. /pstrongJob Description /strongpThe 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. /ppThis is a part time assignment for 0.5 FTE. /pulliAct as the main line of communication between the Sponsor or CRO and the site. /liliEnsure response to feasibility questions are provided in due time. /liliAssist in scheduling and preparation for all types of monitoring visits at the medical institution/research center. /liliBe present and available to respond to monitors during all types of monitoring visits conducted at the medical institution. /liliTrack patient enrollment and actively support the medical site and CRO/Sponsor team in meeting project timelines and enrollment goals. /liliMaintain study specific and general tracking of documents at the site level. /liliAccurate and timely data entry into study specific EDC systems and timely resolution of data clarification queries issued for the site. /liliTimely reporting and follow up on Reportable Adverse Events and Protocol Deviations. /liliProper handling, accountability and reconciliation of investigational products and clinical supplies. /liliCollect, handle and maintain all site-specific regulatory documents as needed. /liliFacilitate and support the contract and budget negotiations at the site level. /liliSupport Investigator and Site payments and processes as needed. /liliSchedule and/or perform study procedures as per study requirements and delegation of responsibilities. /liliPrepare for and participate in onsite study audits or regulatory agency inspections. /li /ulstrongQualifications /strongulliA university degree in Life Science, preferably in pharmacy, nursing or lab analytics. /liliMinimum of 2 years of on-the-job experience as a Site Coordinator. /liliAbility to work in a fast-paced environment, with short timelines and multiple tasks to be completed simultaneously. /liliAbility to effectively communicate in stressful situations and demonstrate the ability to problem-solve in an effective and efficient manner. /liliValid US Driver's License with the ability to travel as needed. /liliFlexibility in working hours may be required depending on the schedule of study procedures and/or patient visits. /li /ulstrongAdditional Information /strongpIf 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. /ph3Seniority level /h3ulliEntry level /li /ulh3Employment type /h3ulliPart-time /li /ulh3Job function /h3ulliResearch /liliPharmaceutical Manufacturing /li /ul #J-18808-Ljbffr