PSI CRO
Pharmaceuticals
ClinicalTrialsLeadSiteCoordinator
Neural analysis suggests this role is
optimal for mid candidates.
“Clinical Trials Lead Site Coordinator at PSI CRO. Skills: Site coordination, Clinical study support, Client relationships. Act as main line of communication. Ensure response to feasibility questions”
What You'll Achieve.
Meet project timelines; Meet enrollment goals
Industry & Context.
Problem-solve in an effective manner; Problem-solve in an efficient manner
Flexibility in working hours
What They're Looking For.
Must Have
College or university degree, Minimum of 2 years of on-the-job experience in a clinical trial environment, Relevant experience in clinical trials, Relevant experience in clinical terminology, Relevant experience in medical research, Experience in the role of a Study Coordinator or similar function, Upper-intermediate level of English
Nice to Have
Experience in Oncology, Experience in Renal, Experience in Cardiology clinical studies, Interest in professional growth and development
What You'll Do.
Act as main line of communication
Ensure response to feasibility questions
Assist in scheduling monitoring visits
Assist in preparation for monitoring visits
Be present during monitoring visits
Respond to monitors during visits
Track patient enrollment
Support meeting project timelines
Support meeting enrollment goals
Maintain study specific tracking of documents
Maintain general tracking of documents
Accurate data entry into EDC systems
Timely resolution of data clarification queries
Timely reporting on adverse events
Timely reporting on protocol deviations
Follow up on adverse events
Follow up on protocol deviations
Proper handling of investigational products
Proper handling of clinical supplies
Accountability of investigational products
Accountability of clinical supplies
Reconciliation of investigational products
Reconciliation of clinical supplies
Collect site-specific regulatory documents
Handle site-specific regulatory documents
Maintain site-specific regulatory documents
Facilitate contract negotiations
Facilitate budget negotiations
Support Investigator payments
Support Site payments
Support Investigator processes
Support Site processes
Schedule study procedures
Perform study procedures
Prepare for onsite study audits
Participate in onsite study audits
Prepare for regulatory agency inspections
Participate in regulatory agency inspections
Build client relationships
Sustain client relationships
How You'll Work.
Team & Collaboration
Global team environment; Site and CRO/Sponsor team
Communication Scope
Communication in stressful situations
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. Please submit CV in English. 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. * Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions). ## Qualifications * College or university degree in Life Science
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