Clinical Research Associate- Serbia

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

ProPharma is seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our growing Clinical Research Solutions team in Serbia.

Due to the award of new studies and exceptionally strong patient recruitment activity that exceeded forecasts, we are expanding our local CRA team to support ongoing and future operations.

Position Summary

The Clinical Research Associate position is responsible for clinical monitoring of assigned protocols and investigational sites while ensuring studies are conducted and documented in accordance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH guidelines, and all applicable local and international regulatory requirements.

Key Responsibilities

• Conduct all types of monitoring visits, including qualification, site initiation, interim, co-monitoring and close-out visits, both on-site and remotely.
• Prepare, complete and submit monitoring reports in accordance with SOP timelines and local regulatory requirements.
• Support study start-up activities, including feasibility assessments, site identification, collection of essential documents and Ethics Committee submissions where applicable.
• 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 while proactively resolving data issues.
• Manage investigational product accountability activities, 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.