Clinical Research Associate – Sponsor Dedicated (Serbia)

About the role

The Clinical Research Associate will perform monitoring and site management to ensure studies are conducted according to protocol, regulations and sponsor requirements. This position is dedicated to sponsor‑driven projects in Serbia.

Key responsibilities

• Conduct site monitoring visits, including selection, initiation, ongoing monitoring and close‑out.
• Support sites in developing and tracking subject recruitment plans.
• Provide protocol and study training to sites and maintain regular communication.
• Evaluate site practices for quality, regulatory compliance and protocol adherence, escalating issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries and ensure proper documentation in the Trial Master File.
• Maintain Investigator’s Site File in line with GCP/ICH and local regulations.
• Prepare visit reports, follow‑up letters and other required study documentation.
• Collaborate with study team members for project execution support.
• Manage site financials according to clinical trial agreements and retrieve invoices when required.

Required profile

• Bachelor’s degree in a scientific discipline or healthcare (preferred).
• At least 1 year of CRA and on‑site monitoring experience.
• Strong organizational, problem‑solving and time‑management abilities.
• Effective written and verbal communication skills in English and Serbian.
• Valid driver’s license and ability to travel within Serbia.

Required skills

• Proficiency with IT tools and systems (IT literate).
• Knowledge of GCP/ICH guidelines and local regulatory requirements.
• Fluency in English and Serbian.