Senior Clinical Research Associate – Contractor
Location: Serbia
Department: Clinical Operations
Company: Biorasi
Employment Type: Contract
Estimated Salary: €45,000 – €68,000 annually (based on Serbia’s clinical research market and experience)
About Biorasi:
Biorasi is an award-winning, full-service CRO recognized for innovation, collaboration, and flexibility. We focus on accelerating life-changing therapies to patients globally while maintaining a strong work-life balance for our teams. Join our rapidly growing organization and play a vital role in the future of clinical research.
Key Responsibilities:
Site Management & Monitoring:
Plan and execute Site Selection, Initiation, Interim Monitoring, and Close-out Visits.
Document all visits with detailed reports and follow-up letters.
Trial Oversight & Compliance:
Track submissions, subject enrollment, CRF completion, and query resolution.
Coordinate the supply chain for investigational products and lab materials.
Perform IP inventory checks and manage returns or destruction per protocol.
Clinical Operations Support:
Participate in and prepare for Investigator Meetings.
Review documentation for adherence to protocol and GCP guidelines.
Collect and archive essential documents in the eTMF system.
Training & Communication:
Conduct training for site personnel on protocol and study expectations.
Serve as the site’s primary contact for operational issues.
Escalate safety and compliance concerns to the project team.
Project Coordination & Leadership:
Collaborate with the Clinical Trial Manager to resolve performance issues.
Support protocol and study document development when requested.
Lead or support CRA trainings and team meetings.
Track performance metrics and contribute to overall project analysis.
Mentorship & Development:
Mentor junior associates and guide professional growth.
Support QA audits and address audit findings.
Candidate Profile:
Education: Bachelor's in Biomedical Sciences or related field.
Experience:
Minimum of 3 years in clinical monitoring.
Experience as CRA, CRC, or related research roles is an asset.
Skills:
Fluency in English and Serbian (spoken and written).
Strong understanding of ICH-GCP and regulatory compliance.
Proficient in MS Office (Word, Excel, PowerPoint).
Strong planning, leadership, and communication skills.
Other Requirements:
Willingness to travel up to 70%.
Detail-oriented with analytical mindset.
How to Apply:
Apply online at https://biorasi.com or email your resume to careers@biorasi.com.
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