Clinical Site Coordinator

About the role

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland, supporting clinical study sites in stronger study delivery. It is hiring a Site Coordinator to work on clinical trials in the southern region of Serbia. The coordinator acts as the main link between the sponsor or CRO and the site, ensuring response to feasibility questions in due time and helping the site meet project timelines and enrollment goals.

Key responsibilities

• Schedule and prepare for monitoring visits and be available to respond to monitors during them.
• Track patient enrollment and support the site and CRO/Sponsor team in meeting timelines and enrollment goals.
• Maintain study-specific and general document tracking at site level, enter data accurately and on time into EDC systems, and resolve data queries.
• Report and follow up on reportable adverse events and protocol deviations, and reconcile investigational products and clinical supplies.
• Collect and maintain site-specific regulatory documents, and support contract and budget negotiations, investigator and site payments, and study procedures.
• Prepare for and take part in onsite study audits or regulatory agency inspections, and build 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.
• Upper-intermediate English and fluency in Serbian.
• Ability to work in a fast-paced environment with short timelines and multiple simultaneous tasks, and to solve problems under pressure.
• Flexibility in working hours may be required depending on study schedules and patient visits.