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Senior Clinical Research Associate, Contractor, Romania

3+ years
€50,000 – €70,000 per year
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Research Associate – Contractor
Location: Romania
Department: Clinical Operations
Company: Biorasi
Employment Type: Contract
Estimated Salary: €50,000 – €70,000 per year (depending on experience and market standards)


About Biorasi:
Biorasi is an award-winning, full-service CRO known for agility, innovation, and impactful collaboration. We empower professionals to lead global clinical research initiatives and deliver breakthrough therapies to patients worldwide. Join our growing international team and help shape the future of clinical development.


Key Responsibilities:

  • Site Monitoring and Execution:

    • Conduct Site Selection, Initiation, Interim Monitoring, and Close-out Visits.

    • Prepare detailed reports and follow-up documentation.

  • Trial Oversight:

    • Track IRB submissions, patient recruitment, CRF submissions, and data queries.

    • Coordinate delivery of IPs, lab supplies, CRFs, and study materials to clinical sites.

    • Monitor investigational product inventory, return, or destruction as needed.

  • Compliance and Documentation:

    • Review site files, study documents, and protocol compliance.

    • Ensure documentation accuracy in line with ICH-GCP and regulatory standards.

    • Collect and file essential documents in eTMF.

  • Team Communication and Training:

    • Train site personnel and maintain regular site communication.

    • Identify and escalate protocol deviations or safety concerns.

    • Attend Investigator Meetings and team teleconferences.

  • Project Coordination and Leadership:

    • Provide updates to the project management team.

    • Assist in audit preparations and support quality assurance planning.

    • Mentor junior CRAs and contribute to performance analysis and feedback.

  • Documentation Review Support:

    • Contribute to protocol and study manual review upon request.

    • Support team performance tracking and cross-functional collaboration.


Your Profile:

  • Education: Bachelor's degree in Biomedical Sciences or related field.

  • Experience: Minimum 3 years of monitoring experience, preferably with CRA/CRC background.

  • Skills & Proficiency:

    • Advanced understanding of ICH-GCP and global regulatory requirements.

    • Excellent verbal and written communication skills in English and Romanian.

    • Strong project management, planning, and leadership abilities.

    • Proficient with MS Word, PowerPoint, Excel.

  • Other:

    • Willingness to travel up to 70% based on trial needs.

    • Detail-oriented with scientific acumen and quality-focused approach.


Apply Now:
Submit your application at
biorasi.com or email your resume to careers@biorasi.com.