Join our Talent Pool - Sr Clinical Research Associate ( Croatia)

As a Senior Clinical Research Associate based in Croatia, you will play a key role in the successful delivery of clinical trials by independently managing clinical site monitoring and site management activities across Croatia, Serbia and Bosnia, from study start-up through close-out. You will act as a primary point of contact for investigative sites across these countries, ensuring compliance with protocols, ICH-GCP, applicable local regulations and study requirements while supporting high-quality patient data and study delivery.

This is a senior individual contributor role with responsibility for supporting site performance, resolving issues, maintaining study documentation and providing guidance and mentorship to junior CRAs. You will work closely with Clinical Operations, Project Management, sponsors and other cross-functional teams in a dynamic clinical research environment.

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Croatia, Serbia and Bosnia and Herzegovina.

• Ensure investigative sites comply with study protocols, ICH-GCP, applicable local regulations, SOPs and project-specific requirements.

• Serve as a primary point of contact for assigned sites, managing site-related questions, issues, action items and protocol deviations through to resolution.

• Review clinical trial data, source documentation and study systems to ensure accuracy, completeness, data integrity and compliance.

• Support site selection, activation and recruitment activities, working with sites to achieve study milestones and patient recruitment targets.

• Ensure sites are appropriately trained on protocols, study systems, processes and applicable requirements throughout the study lifecycle.

• Maintain oversight of essential study documentation, including ISF and TMF, ensuring documents are complete, accurate and filed in a timely manner.

• Collaborate with sponsors, project teams, vendors and investigative sites across the three countries to support study timelines, resolve issues and maintain effective working relationships.

• Participate in audits and inspections, Investigator Meetings, study meetings and other project activities as required.

• Provide mentoring and support to CRA I and II colleagues, participate in co-monitoring and CRA assessment activities, and contribute to process improvement initiatives.

• Bachelor's degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master's degree is preferred.
• 4–6 years of relevant clinical research experience, with 7–9 years preferred.
• Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out.
• Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements.
• Experience with Phase I–IV clinical trials preferred.
• Proficiency with clinical trial systems such as EDC, IRT, eTMF, CTMS and Microsoft Office, with experience in systems such as Medidata Rave or Oracle InForm preferred.
• Strong understanding of site management, including site activation, recruitment, training, issue resolution and maintenance of essential documentation.
• Excellent communication, interpersonal and relationship-management skills, with the ability to work effectively with investigative sites, sponsors and cross-functional teams.
• Strong organizational, problem-solving and prioritization skills, with a high level of attention to detail and a sense of urgency.
• Ability to work independently, demonstrate sound judgement and manage competing priorities in a results-driven environment.
• Experience mentoring or supporting junior CRAs is preferred.
• Based in Croatia, with willingness and ability to travel approximately 40–60% across Croatia, Serbia and Bosnia, depending on project requirements.
• Valid driver's license required.
• Fluent written and verbal English.