Company DescriptionMilestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our mission is to support sites in stronger study delivery.Job DescriptionAs a Milestone One Site Coordinator you will supports study sites in all trial related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.Based in Rijeka, CroatiaIn this role you will:
Act as the main line of communication between the Sponsor or CRO and the site.
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.
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.
Qualifications
College or university degree in Life Sciences, preferably in pharmacy, nursing or lab analytics.
Prior experience in clinical trial environment
Full proficiency in Croatian and intermediate English language proficiency.
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.
Own car and valid Driver's License with the ability to travel as needed.
Flexibility in working hours may be required depending on the schedule of study procedures and/or patient visits.
Additional InformationIf 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.
