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    Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

    Syneos Health
    2+ years
    Not Disclosed
    Bulgaria
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote 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

    Position: Clinical Research Associate II / Senior Clinical Research Associate

    Company: Syneos Health
    Location: Global (with travel up to 75%)

    Discover a career where your work truly matters, with Syneos Health.
    As a fully integrated biopharmaceutical solutions organization, we collaborate with innovative problem-solvers to bring life-changing therapies to market. Our agile and passionate team empowers customers and patients, driving clinical success worldwide.

    Key Responsibilities

    Your primary role is to oversee site qualification, monitoring, and management to ensure compliance with clinical protocols and regulatory standards.

    Core Duties

    1. Site Management & Monitoring:

      • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
      • Ensure regulatory, ICH-GCP, and protocol compliance at all times.
      • Evaluate site performance and develop action plans for underperformance.

    2. Data Integrity & Compliance:

      • Review and verify informed consent documentation.
      • Perform Source Document Reviews (SDR) and confirm data accuracy in CRFs.
      • Resolve queries promptly and guide site staff to ensure compliance with electronic data capture requirements.

    3. Investigational Product (IP) Oversight:

      • Verify proper IP storage, dispensing, reconciliation, and compliance with protocol requirements.

    4. Documentation & Reporting:

      • Maintain accurate, timely records in ISFs and TMFs.
      • Provide clear trip reports, communication logs, and follow-up letters per SOPs and Clinical Monitoring Plans.

    5. Collaboration & Communication:

      • Act as the primary liaison with study sites and external stakeholders, including medical science liaisons and local healthcare providers.
      • Support audit readiness and contribute to global clinical project meetings and training.

    6. Real World Late Phase (RWL):

      • Assist with site lifecycle management and data collection for late-phase studies.
      • Collaborate with sponsor affiliates and train junior staff as needed.

    Qualifications

    We are looking for experienced clinical professionals with a passion for excellence and the drive to innovate.

    Education & Experience:

    • Bachelor's degree or RN in a related field.
    • Strong knowledge of ICH/GCP Guidelines and regulatory requirements.
    • Minimum 2+ years of experience in clinical research roles.

    Skills & Competencies:

    • Exceptional computer literacy and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Proven ability to manage travel up to 75% and handle shifting priorities.
    • Familiarity with chart abstraction and late-phase study requirements is a plus.

    Why Syneos Health?

    Be Part of the Total Self Culture:
    Syneos Health believes in creating an environment where you can authentically be yourself. Through diverse perspectives, we achieve innovative solutions for patients worldwide.

    Career Development:

    • Tailored career progression opportunities.
    • Access to technical and therapeutic training.
    • Global exposure across various therapeutic areas and regions.

    Recognition & Rewards:

    • Peer recognition programs and competitive compensation.
    • Opportunities to work on groundbreaking FDA/EMA projects and clinical trials.

    Additional Information

    This role will expose you to diverse responsibilities and cutting-edge therapies. Syneos Health is committed to compliance with global employment laws and providing reasonable accommodations.

    Explore an impactful career and join Syneos Health to help transform lives worldwide. Apply now and learn more at Syneos Health Careers.

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