Milestone One
Healthcare
SiteCoordinator
Neural analysis suggests this role is
optimal for mid candidates.
“Site Coordinator at Milestone One. Skills: Site coordination, Clinical study support. Act as main line of communication. Ensure response to feasibility questions”
What You'll Achieve.
Meet project timelines; Meet enrollment goals
Industry & Context.
Problem-solving
Flexibility in working hours
What They're Looking For.
Must Have
2 years on-the-job experience as a site coordinator, Fluent Polish, Fluent English
Nice to Have
University degree in Life Science, Degree in pharmacy, Degree in nursing, Degree in lab analytics
What You'll Do.
Act as main line of communication
Ensure response to feasibility questions
Assist in scheduling monitoring visits
Be present during monitoring visits
Track patient enrollment
Support meeting project timelines
Maintain study specific tracking
Maintain general tracking of documents
Timely resolution of data clarification queries
Timely reporting of adverse events
Timely reporting of protocol deviations
Proper handling of investigational products
Accountability of clinical supplies
Reconciliation of investigational products
Reconciliation of clinical supplies
Collect site-specific regulatory documents
Maintain site-specific regulatory documents
Facilitate contract negotiations
Facilitate budget negotiations
Support Investigator payments
Support Site payments
Schedule study procedures
Perform study procedures
Prepare for study audits
Prepare for regulatory agency inspections
Participate in study audits
Participate in regulatory agency inspections
How You'll Work.
Team & Collaboration
Site team; CRO team; Sponsor team
Full Job 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. 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. The function of the role may include, but not limited to, any/all of the following: * 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. ## Qualifications * A university degree in Life Science, preferably in pharmacy, nursing or lab analytics. * Minimum of 2 yea
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