Clinical Research Associate – Sponsor Dedicated

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. The role supports subject recruitment, data quality, and regulatory compliance across assigned sites in Serbia.

Key responsibilities

• Conduct site monitoring visits, including selection, initiation, ongoing monitoring, and close‑out.
• Drive and track subject recruitment plans in line with project needs.
• Provide protocol training, maintain regular communication, and manage site expectations.
• Evaluate site practices for quality and regulatory adherence, escalating issues as needed.
• Track regulatory submissions, enrollment, CRF completion, and data query resolution.
• Maintain site documentation in the Trial Master File and ensure Investigator Site Files meet GCP/ICH standards.
• Prepare visit reports, follow‑up letters, and other study documentation.
• Collaborate with study team members for project execution support.

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 skills.
• Effective written and verbal communication in English and Serbian.
• Valid driver’s license and active driver status in Serbia.

Required skills

• IT literacy
• English language proficiency
• Serbian language proficiency