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    Senior Clinical Research Associate Contractor

    Biorasi
    3+ years
    Not Disclosed
    Greece
    10 Dec. 24, 2024
    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

    Job Opportunity: Clinical Research Associate (CRA)
    Company: Biorasi

    About Biorasi
    Biorasi is an award-winning, customer-focused, full-service clinical research organization. We offer an innovative, collaborative, dynamic, and evolving work environment that emphasizes work-life balance and professional growth. Join our passionate team to drive new therapies to patients worldwide.

    Your Role

    As a Clinical Research Associate (CRA), you will play a pivotal role in the successful execution of clinical trials. Key responsibilities include:

    • Site Visits: Schedule, plan, and conduct Site Selection Visits, Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits.
    • Documentation & Reporting: Write detailed reports and investigator follow-up letters for site visits and review study documents for compliance with protocol and ICH GCP guidelines.
    • Study Management: Manage study progress, including tracking IRB submissions and approvals, recruitment and enrollment, CRF completion, and resolution of data queries.
    • Investigational Product Oversight: Organize delivery and inventory of investigational products, laboratory supplies, and other study-specific materials.
    • Regulatory Compliance: Evaluate quality and adherence to study protocols, escalate issues as needed, and follow international GCP guidelines and SOPs.
    • Training & Communication: Provide protocol and study training to sites, establish communication lines, and participate in Investigator Meetings.
    • Team Collaboration: Assist Clinical Trial Managers with site performance oversight, provide feedback to CRAs and CTAs, and partake in regular team meetings.
    • Mentorship: Act as a mentor for associates, providing guidance on job performance and professional development.
    • Quality Assurance: Participate in the planning of QA activities, coordinate resolution of audit findings, and assist in reporting site performance.
    • Leadership Duties: May review protocols, eCRFs, study manuals, and train CRAs as required.

    Other duties as assigned.

    Your Profile

    • Education:
      • Bachelor’s degree in biomedical sciences or a related scientific discipline.
    • Experience:
      • Minimum of 3 years of monitoring experience, with a combination of clinical research coordination or other relevant clinical research roles.
    • Skills & Knowledge:
      • Advanced proficiency in clinical monitoring processes and sound knowledge of medical terminology.
      • Familiarity with ICH GCP guidelines and worldwide applicable regulatory requirements.
      • Strong leadership, planning, and project management skills.
      • Excellent verbal and written communication skills.
      • Proficiency in MS Office (Word, PowerPoint, Excel).
    • Other Requirements:
      • Fluent in English (oral and written) and applicable local business language.
      • Ability to travel up to 70% based on project needs.

    Why Join Biorasi?

    We prioritize employee well-being by offering benefits tailored to enhance health and work-life balance, including:

    • Half-day Fridays.
    • Paid time off and holidays.
    • Comprehensive country-specific benefits.
    • Employee bonus programs.
    • Opportunities for career growth, training, and development.

    Apply Now

    If you meet the qualifications and want to join a creative, collaborative, and fast-paced team, apply at our Careers Page or email us at careers@biorasi.com.

    Diversity and Inclusion

    Biorasi is an equal-opportunity employer committed to fostering diversity and inclusion. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We also comply with fair employment practices regarding citizenship and immigration status.

     

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