Company Description

Milestone 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.

Job Description

Milestone One Site Coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements within Study specific defined timelines and enrollment goals.

In this role you will:

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.

QualificationsCollege or university degree in Life Science, preferably in pharmacy, nursing or lab analytics.2-3 years of site coordinating experience is requiredAbility to multitask across various protocolsEnglish - Spanish bilingualAbility to work on SaturdaysExperience with eSource systems (preferred)Experience in cardiometabolic and/or GI trials

Additional Information

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.