Clinical Research Associate (Serbia)

About the role

ProPharma is looking for a motivated and detail‑oriented Clinical Research Associate to join its Clinical Research Solutions team in Serbia. The role focuses on clinical monitoring of assigned protocols and investigational sites, ensuring compliance with study protocols, SOPs, GCP, ICH guidelines and local and international regulations.

Key responsibilities

• Conduct qualification, site initiation, interim, co‑monitoring and close‑out visits both on‑site and remotely.
• Prepare and submit monitoring reports in line with SOP timelines and regulatory requirements.
• Support study start‑up activities, including feasibility assessments, site identification, essential document collection and Ethics Committee submissions.
• Develop and maintain study‑specific monitoring documentation, trackers, monitoring plans, source templates and site tools.
• Train investigators and site staff on protocol requirements, source documentation standards and case report form completion.
• Review source documentation and case report forms to ensure data accuracy, completeness and integrity, and proactively resolve data issues.
• Manage investigational product accountability, including shipment, tracking, inventory management and reconciliation.
• Monitor site enrolment, protocol deviations, serious adverse events, laboratory abnormalities and all study‑related activities to ensure protocol compliance.
• Review regulatory documentation for completeness and accuracy and support sites with regulatory requirements as needed.
• Maintain effective communication with investigators, site personnel, sponsors and internal cross‑functional teams.
• Participate in project meetings, sponsor calls and cross‑functional discussions supporting study execution.

Required profile

• Motivated and detail‑oriented professional with a strong interest in clinical research.

Required skills

• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.