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    Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

    Syneos Health
    0-2 years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description: Clinical Research Associate II / Senior Clinical Research Associate

    Location: Syneos Health

    Company Overview:

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, designed to accelerate customer success. With a focus on translating clinical, medical affairs, and commercial insights into impactful outcomes, Syneos Health thrives in simplifying and streamlining clinical development processes. The company's global team of 29,000 employees across 110 countries work collaboratively to drive innovation and deliver therapies that change lives. Syneos Health fosters an environment where both employees and clients thrive, emphasizing a culture of diversity, inclusion, and personal growth.

    Role Overview:

    As a Clinical Research Associate II / Senior Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials through effective site management and monitoring. This role involves performing site qualification, initiation, monitoring, and close-out visits (both remotely and on-site), ensuring compliance with regulatory standards, ICH-GCP, and protocol adherence.

    Key Responsibilities:

    • Site Monitoring & Management:

      • Perform site qualification, initiation, monitoring, and close-out visits, ensuring all activities comply with regulatory, ICH-GCP, and protocol requirements.
      • Evaluate the overall performance of the site and provide site-specific recommendations.
      • Communicate and escalate serious issues to the project team promptly, developing corrective action plans as necessary.

    • Clinical Data Review & Query Resolution:

      • Review source documents and case report forms (CRFs) to verify data accuracy and completeness.
      • Provide guidance to site staff and resolve data queries efficiently, ensuring resolution within agreed timelines.
      • Ensure compliance with electronic data capture and data management systems.

    • Informed Consent & Safety Monitoring:

      • Verify that the informed consent process has been conducted appropriately and documented for each subject.
      • Monitor patient safety and clinical data integrity, addressing protocol deviations and pharmacovigilance issues as they arise.

    • Investigational Product (IP) Management:

      • Perform investigational product inventory, reconciliation, and ensure proper storage, dispensing, and administration according to the protocol.
      • Ensure proper handling of blinded or randomized information regarding IP.

    • Documentation & Compliance:

      • Ensure the Investigator Site File (ISF) is accurate, complete, and reconciled with the Trial Master File (TMF).
      • Maintain accurate records of site activities, including confirmation letters, trip reports, and follow-up communications.
      • Provide documentation of observations, action items, and resolutions in tracking systems.

    • Project & Site Management:

      • Manage site-level activities to ensure project objectives, timelines, and deliverables are met.
      • Collaborate with the project team and site personnel to maintain compliance with project scope and timelines.
      • Participate in global clinical monitoring/project staff meetings and provide input into study planning.

    • Training & Mentorship:

      • May provide training and mentorship to junior staff and ensure that all team members comply with required protocols and training.
      • Support audit readiness by ensuring sites and projects meet audit standards.

    • Late Phase/Real-World Studies:

      • For real-world late phase studies, support site activities throughout the study lifecycle, including site identification, chart abstraction, and data collection.
      • Work with sponsors, medical science liaisons, and local teams to ensure successful project execution.

    Qualifications:

    • Education:

      • Bachelor’s degree or Registered Nurse (RN) qualification in a related field, or an equivalent combination of education, training, and experience.

    • Experience & Skills:

      • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
      • Strong computer skills and adaptability to new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to manage significant travel requirements (up to 75%).

    • Additional Skills:

      • Ability to manage multiple priorities, adapt to changing circumstances, and drive resolutions proactively.
      • A collaborative team player with a passion for improving healthcare outcomes.

    Why Syneos Health?

    Syneos Health values its people and provides opportunities for career development, progression, and technical training. The company fosters an inclusive and diverse environment where employees can bring their authentic selves to work. Additionally, Syneos Health offers a comprehensive Total Rewards program and benefits designed to prioritize your well-being and work-life balance.

    Interested in Joining Syneos Health?
    If you're passionate about clinical research and eager to contribute to impactful medical innovations, we invite you to apply for this opportunity to make a difference in patient care and clinical development.

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