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    Sponsor Dedicated Cra Ii - Remote

    Syneos Health
    0-5 years
    Not Disclosed
    Remote, USA
    15 June 10, 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, 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: Sponsor Dedicated Clinical Research Associate II

    Location: Home Based, Italy

    Employment Type: Full-time

    About Syneos Health: Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model prioritizes the customer and patient, aiming to simplify and streamline processes to make Syneos Health easier to collaborate with and work for.

    Why Syneos Health:

    • Commitment to employee development, career progression, and supportive management.
    • Total Self culture fostering authenticity and unity globally.
    • Building an inclusive workplace where diversity of thoughts, backgrounds, cultures, and perspectives create a sense of belonging.

    Responsibilities:

    1. Conduct site qualification, initiation, monitoring, and close-out visits ensuring regulatory and protocol compliance.
    2. Evaluate site performance, escalate serious issues to the project team, and develop action plans.
    3. Verify informed consent process, protect subject/patient confidentiality, and assess factors affecting safety and data integrity.
    4. Assess site processes, conduct Source Document Review, and ensure accuracy of clinical data.
    5. Resolve queries, guide site staff, and ensure timely query resolution.
    6. Utilize hardware and software for effective clinical study data review and capture.
    7. Verify site compliance with electronic data capture requirements.
    8. Perform investigational product inventory, reconciliation, and ensure compliance with GCP/local regulations.
    9. Review Investigator Site File for accuracy and completeness, reconcile with Trial Master File.
    10. Document activities per SOPs, support subject/patient recruitment and retention.
    11. Manage site-level activities, adapt to changing priorities, and ensure project objectives are met.
    12. Act as a liaison with study site personnel and participate in meetings and training sessions.
    13. Provide guidance on audit readiness standards, support audit preparation, and follow-up actions.

    For Real World Late Phase:

    • Provide site support throughout the study lifecycle.
    • Conduct chart abstraction activities and data collection.
    • Collaborate with Sponsor affiliates, medical science liaisons, and local country staff.
    • Train junior staff and identify out of scope activities.
    • Suggest potential sites based on local knowledge.

    Qualifications:

    • Bachelor’s degree or RN in a related field or equivalent.
    • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication and interpersonal skills.
    • Ability to manage required travel of up to 75% regularly.

    Additional Information: Tasks, duties, and responsibilities may vary. Equivalent experience, skills, and education considered. The Company determines equivalence. Committed to compliance with relevant legislation and providing reasonable accommodations.

    Apply for this Job: [Apply Here]

    Not ready to apply? Join our Talent Network.

    At Syneos Health, diversity and inclusion are core values. Encourages applying regardless of perfect alignment with past experience. Join Talent Network for additional opportunities.

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