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.
• 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.
• Perform additional duties as required to support project delivery.

Required Qualifications

• Bachelor's degree or an equivalent combination of education and experience.
• Minimum 2 years of on-site monitoring experience as a Clinical Research Associate.
• Cardiology therapeutic area experience is essential.
• Experience with 6–9 on-site monitoring days per month.
• Knowledge of ICH-GCP guidelines, local regulations and clinical trial requirements.
• Experience using EDC systems, CTMS, IVRS and eTMF platforms.
• Strong Microsoft Office skills, including Outlook, Word, Excel and PowerPoint.
• Excellent written and verbal communication skills in English and Serbian.

What We Are Looking For

The successful candidate will be a proactive and collaborative clinical research professional who thrives in a dynamic environment and is passionate about delivering high-quality clinical trials while maintaining the highest standards of patient safety, data integrity and regulatory compliance.

If you are looking to join a growing team and contribute to the successful delivery of innovative clinical research programmes, we would like to hear from you.

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***