Clinical Research Associate In RWE Department - Croatia - Remote Eligible

Clinical Research Associate – Real World Evidence

Level: Assoc CRA (gr 131)- CRA 1(gr 132) - CRA 2 (gr 133) - Sr CRA 1 (gr 141)

Job Overview

The Clinical Research Associate (CRA) within the Real World Evidence (RWE) department is responsible for monitoring and management of observational studies. The role largely focuses on remote activities, with regular on-site visits performed at moderate volume (approx. 1-3 per month).

The CRA acts as the primary point of contact for assigned sites in both Croatia and Slovenia, supporting strong site relationships, efficient issue resolution, and timely study execution. This is a home-based position in Croatia, offering a good work-life balance in a friendly, motivating and professional environment.

Essential Functions

• Perform remote and on-site monitoring activities in accordance with the contracted scope of work.
• Serve as the main point of contact for assigned clinical sites, maintaining regular communication to support study conduct, resolve issues, and manage expectations throughout the study lifecycle.
• Oversee and manage site activities for Phase IV observational studies, ensuring protocol adherence and compliance with applicable regulatory and local requirements.
• Track, manage, and open/close site-related action items, ensuring follow-up, documentation, and escalation as needed.
• Evaluate the quality and integrity of site data and study conduct, identifying risks and escalating quality or compliance issues appropriately.
• Ensure that all required site documents are collected and maintained, confirming that the Investigator Site File (ISF) and Trial Master File (TMF) are complete and accurate.
• Prepare and maintain comprehensive study documentation, including monitoring reports, follow-up communications, and site correspondence, in a timely and compliant manner.
• Collaborate with internal cross-functional teams to ensure smooth study execution and issue resolution.
• Provide protocol, study, and system training to sites as required, supporting consistent understanding of observational study requirements.
• Contribute to continuous process improvement initiatives within the RWE department, focusing on efficiency, quality, and site satisfaction.

Qualifications & Experience

• Bachelor's degree in Life Sciences, Health Sciences, or a related field.
• 1-3 years of experience with on-site and/or remote monitoring preferred.
• Also open to more junior candidates with some prior experience in Clinical Trials or CRA trainee roles.
• Ability to manage assigned sites independently, including communication, issue resolution, action item tracking, and study documentation.
• Comfortable working in a primarily remote monitoring environment, using electronic systems and maintaining strong site relationships without frequent on-site presence.
• Strong organizational, time management, and problem-solving skills, with attention to detail and quality.
• Excellent written and verbal communication skills; ability to act as a trusted primary point of contact for sites.
• Proficiency in English and Croatian.
• A valid driver´s license, willingness to travel within Croatia and Slovenia.