Clinical Site Coordinator

About the role

Milestone One, a Site Enabling Services organization with headquarters in Zug, Switzerland, is hiring a Clinical Site Coordinator in the southern region of Serbia. The coordinator supports trial sites in all related activities according to ICH-GCP, protocol requirements, study-specific timelines and enrollment goals, acting as the main link between the sponsor/CRO and the site.

Key responsibilities

• Respond to feasibility questions in due time and assist in scheduling and preparing monitoring visits, staying available to monitors during them
• Track patient enrollment and help the site meet project timelines and enrollment goals
• Maintain study-specific and general document tracking, enter data accurately and on time into EDC systems and resolve data clarifications
• Report and follow up on reportable adverse events and protocol deviations
• Handle, account for and reconcile investigational products and clinical supplies, and collect and maintain site regulatory documents
• Support contract and budget negotiations, investigator and site payments, and schedule or perform study procedures
• Prepare for and take part in onsite study audits or regulatory agency inspections
• Build and maintain relationships with sponsors, CROs and medical institutions

Required profile

• College or university degree in Life Sciences, preferably pharmacy, nursing or lab analytics
• At least 2 years of on-the-job experience in a clinical trial environment, ideally as a Study Coordinator or similar
• Fluency in Serbian and upper-intermediate English, able to work in a global team
• Ability to cope with a fast pace, short timelines and multiple simultaneous tasks, and to solve problems under pressure
• Flexibility in working hours may be required depending on study schedules