PSI CRO AG is hiring a
Site Coordinator

Summary

Join our team as a Site Coordinator at Milestone One, supporting Clinical Study Sites in clinical trial related activities according to ICH-GCP and local regulations. The role involves communication with Sponsor/CRO and site management, data entry, reporting, and regulatory compliance.

Requirements

• A university degree in Life Science, preferably in pharmacy, nursing or lab analytics
• An adequate combination of relevant on the job experience, education and training that confirms the availability of the knowledge, experience, skills and abilities required for the position may be considered
• Minimum of 2 years of on-the-job experience in a clinical trial environment, where relevant experience has been gained in clinical trials, clinical terminology, and medical research working in the role of a Study Coordinator or similar function
• Full working proficiency in Romanian & English
• 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

Responsibilities

• Act as the main line of communication between the Sponsor / CRO and the site
• Assist in scheduling and preparation for all types of monitoring visits at the medical institution/research center, participation during all such visits
• 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 assistance in 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 reconciliations 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