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    Cra Ii- Scra

    Syneos Health
    5+ years
    Not Disclosed
    Remote
    10 Sept. 7, 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 Title: Clinical Research Associate II

    Location: Tokyo, Japan

    About Syneos Health: Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market needs. Our focus is on simplifying and streamlining processes to benefit both our clients and our team.

    With 29,000 employees across 110 countries, we are passionate about making a difference and driving innovation. Our approach puts both the customer and the patient at the heart of everything we do. We aim to be the partner of choice in delivering therapies that transform lives.

    Why Syneos Health:

    • Career Development: We prioritize your growth with career progression, technical and therapeutic training, and a supportive management team.
    • Inclusive Culture: Our Total Self culture promotes authenticity and a sense of belonging.
    • Diverse Environment: We value diverse perspectives and aim to create a workplace where everyone feels included and valued.

    Key Responsibilities:

    • Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely). Ensure compliance with regulatory requirements, ICH-GCP, and protocol guidelines. Evaluate site performance and escalate serious issues as needed.
    • Informed Consent: Verify that informed consent is obtained and documented correctly and ensure patient confidentiality.
    • Data Management: Conduct source document reviews, verify data accuracy in case report forms (CRFs), and resolve queries. Ensure compliance with electronic data capture requirements.
    • Investigational Product (IP): Manage IP inventory, reconciliation, and ensure proper storage, dispensing, and security. Address issues related to blinded or randomized information.
    • Documentation: Maintain and reconcile Investigator Site Files (ISFs) with the Trial Master File (TMF). Ensure accurate documentation and compliance with archiving requirements.
    • Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and adapt to changing priorities.
    • Site Liaison: Act as the primary contact for site personnel, ensuring compliance with requirements. Prepare for and attend Investigator Meetings and other project-related meetings.
    • Audit Readiness: Support audit preparation and follow-up actions, ensuring compliance with audit standards.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other regulatory requirements.
    • Proficient computer skills and ability to embrace new technologies.
    • Strong communication, presentation, and interpersonal skills.
    • Ability to manage travel requirements, up to 75%, on a regular basis.

    Additional Information: The responsibilities and qualifications listed are not exhaustive. Syneos Health may assign other duties as needed. Equivalent experience and skills may be considered. The company is committed to providing reasonable accommodations for employees or applicants with disabilities.

    Join Us: Be a part of a team that values innovation, collaboration, and career growth. Discover how Syneos Health makes a global impact and explore your future with us.

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