In-house Clinical Research Associate (CRA) II

About the role

Precision for Medicine is seeking an In‑house Clinical Research Associate (CRA) II to support multiple clinical studies conducted in Serbia. The CRA II will act as the primary liaison between the sponsor and study sites, ensuring compliance with ICH‑GCP, GPP and local regulations while maintaining high‑quality documentation.

Key responsibilities

• Assist in investigator recruitment using phone scripts, questionnaires and site feasibility assessments.
• Prepare and distribute Investigator Site Files, coordinate shipping of study materials, and manage site‑level documentation in the trial master file (TMF).
• Enter and monitor study milestones in the Clinical Trial Management System (CTMS) and ensure timely data entry in electronic data capture (EDC) systems.
• Serve as the main point of contact for site queries, supply management, and off‑site central monitoring activities.
• Support regulatory submissions, IRB/IEC requirements, and sample logistics as needed.
• Conduct site‑level data review, resolve queries, and assist with database closure and freezing procedures.

Required profile

• Minimum of 2 years experience as a Clinical Research Associate or in a related clinical monitoring role.
• Strong knowledge of ICH‑GCP, GPP and local regulatory guidelines.
• Excellent organizational skills with the ability to work independently and manage multiple studies.

Required skills

• Proficiency with Clinical Trial Management Systems (CTMS).
• Experience using Electronic Data Capture (EDC) platforms.
• Familiarity with trial master file (TMF) management.
• Understanding of site feasibility and recruitment processes.